HORIZON SCANNING MUSCULOSKELETAL PAIN DISORDERS JUNE … · 3 Dietary Supplement 104 Drugs...

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© Arthritis Research UK 2010

HORIZON SCANNING: MUSCULOSKELETAL PAIN DISORDERS

JUNE 2010 The object of these Horizon Scanning reports is to highlight recently completed and ongoing clinical trials, research recommendations and new and emerging health technologies. After feedback from pilot Horizon Scanning exercises and following consultation with the Musculoskeletal pain disorders CSG lead, this first Horizon Scanning report only highlights ongoing clinical trials or those completed during 2008/2009. Details of all material included in this report are shown in the appendix, sorted according to anatomical region involved. Further details of each study can be obtained via the links given to the relevant webpage.

CONTENTS SEARCH METHODOLOGY 3

RESULTS 4

ABBREVIATIONS 5

APPENDIX: CLINICAL TRAILS 6

A1: Hand, Wrist, Finger & Thumb pain………………………………………………. 6

Behavioural, education & exercise including physiotherapy 6

Device 7

Drugs including biologics 8

Other including CAM therapies 12

Miscellaneous observational studies 13

A2: Elbow pain ……………………………………………………………………………….. 14


Device 15



A3: Shoulder pain ……………………………………………………………………………….. 19


Device 22

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Others including CAM therapies 26


A4: Neck pain ……………………………………………………………………………….. 29


Device 32




A5: Back pain…………………………………………………………………………………. 38


Device 49




A6: Hip pain ……………………………………………………………………………….. 87





A7: Knee pain ……………………………………………………………………………….. 88





A8: Foot, Ankle & Toe pain ………………………………………………………….. 92

Device 92




A9: Fibromyalgia ……………………………………………………………………………….. 98


Device 103

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Dietary Supplement 104




A10: Chronic pain ………………………………………………………………………………. 118


Device 122




A11: Pain …….………..……………………………………………………………………………. 135


Device 137

Dietry Supplement 138




SEARCH METHODOLOGY Databases Searched Australian New Zealand Clinical Trials Registry; ClinicalTrials.gov; German Clinical Trials Register; ISRCTN register; MRC Clinical Trials Unit; Nederlands Trials Register; UKCRN Portfolio Database. Keywords searched Hand pain; Wrist pain; Finger pain; Thumb pain; [Meta]carpal pain; Phalangeal pain; Elbow pain; Epicondylitis; Tennis/Golfer’s Elbow; Shoulder pain; Neck pain; Cervical pain; Back pain; Sciatica; Sacroiliac pain; Hip pain; Knee pain; Ankle pain; Foot pain; Toe pain; [Meta]tarsal pain; Chronic [widespread] pain; Fibromyalgia; Pain (as a [musculoskeletal] condition); Musculoskeletal pain. Keywords and phrases were used separately or in combination; truncation was used where possible/applicable. Note: in the case of the Australian New Zealand Clinical Trials Registry the joint/anatomical region was always searched for under the category of musculoskeletal. Conditions excluded from this search

1. Surgical interventions and subsequent rehabilitation programmes, except when

compared to non-surgical interventions

2. Peri- and post-operative pain

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3. Pain resulting from trauma e.g. fracture, dislocation, rotator cuff tears and whiplash

4. Pain primarily associated with a non-musculoskeletal condition e.g. pelvic pain,

cancer-related pain, infection, pregnancy, hemiplegic/post-stroke etc. including

somatoform pain

5. Pain syndromes e.g. Patellofemoral Pain Syndrome

6. Neuropathic pain

7. Headache

8. Facial pain including Temporomandibular Joint disorders

9. Pain associated with osteoarthritis of the knee or hip: these areas attract a

substantial amount of research and are included in the Osteoarthritis and related

disorders CSG’s Horizon Scanning report, available via the Arthritis Research UK

website. Note however, pain associated with osteoarthritis of other joints and in

general is included in this report.

Date limits This report includes trials that were completed or ongoing between May 2008 and May 2010.

RESULTS

Between May 2008 and May 2010, 792 completed or ongoing clinical trails were identified for musculoskeletal pain: these are tabulated in the appendix divided into anatomically distinct sections:

A1: Hand, Wrist, Finger and Thumb pain (n = 41); A2: Elbow pain (n = 27); A3: Shoulder pain (n = 57); A4: Neck pain (n = 50); A5: Back pain (n = 310); A6: Hip pain (n = 7); A7: Knee pain (n = 17); A8: Foot, Ankle and Toe pain (n = 33); A9: Fibromyalgia (n = 126) A10: Chronic pain (n = 112); A11: Pain (n = 98);

For clarity each section is subdivided according to type of intervention: behavioural, device, dietary supplement, drug, other, within which clinical trials are ordered by completion date. Unless otherwise stated in the table trials involve participants of both genders. Each clinical trial has a weblink which can be followed for further details of the study. In the general pain section (A11), diagnosed rheumatic conditions were only included when the focus of the study was pain associated with the pathology as opposed to the treatment of the disease as a whole (this is particularly pertinent to the drug/biologic trials).

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ABBREVIATIONS

Adt Adult (18-65 years) CAM Complementary and Alternative Medicine CBT Cognitive Behavioural Therapy/Treatment Child Child (<18 years) Comp Completed CT ID Clinical Trials Identifier Expand Expanded Access Available F-only Female only Grps Groups Hosp Hospital Invite Invite only M-only Male only MSK Musculoskeletal n Enrollement N/K Not known NR Not recruiting OA Osteoarthritis RA Rheumatoid arthritis Rec Recruiting Recruit Recruitment Sen Senior (>65 years) Susp Suspended. Term Terminated Uni. University Wtdwn Withdrawn

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CLINICAL TRIALS Clinical trials identity number (CT ID): Prefix of NCT denotes National Clinical Trials Identifier and ISRCTN an International Standard Randomized Controlled Trial Number; UKCRN – UK Clinical Research Network; ACTRN – Australian New Zealand Clinical Trials Registry; NTR – Nederland Trial Register; DRK – German clinical Trials Register. Note: Where no end date was given the following were used: completion date for primary outcome measure – italics; last update – preceeded with a ?; start date + final timepoint of outcomes – preceeded with a >.

A1: HAND, WRIST, FINGER & THUMB PAIN

Title Phases: study design (control) CT ID

Interventions Conditions Recruit n Age Grp

Start Date

End Date

Sponsors URL

Behavioural, education & exercise including physiotherapy

SARAH: Stretching and Strengthening for Rheumatoid Arthritis of the Hand: The clinical and cost effectiveness of an exercise programme over and above usual care RCT ISRCTN89936343

Standard care + optimized exercise; Standard care

RA, Hand; RA, Wrist

Active 480 Adt Sen

Nov-08 Apr-12 University of Warwick http://www.controlled-trials.com/ISRCTN89936343

Randomised and controlled study of the effect of ergonomics orientation and motor control exercises in patients with WRUED RCT (active) ISRCTN28200443

Ergonomic orientation + motor control training; ergonomics orientation

Work-related upper extremity disorders Nb: exclusion of diagnosed fibromyalia or rheumatic disease

Active 60 Aadt Aug-10 Apr-11 Federal University of Juiz de Fora, Brazil

http://www.controlled-trials.com/ISRCTN28200443

The efficacy of a multidisciplinary treatment program in patients with osteoarthritis of the hands. RCT (active) NTR1191

Multidisciplinary treatment program; Education + instruction about exercises

Hand OA Active 150 N/K Jan-08 Jan-11 Dutch Arthritis Association

http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1191







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Effectiveness of Occupational Therapy in Patients With Rheumatoid Arthritis (RCT) RCT (active), Efficacy Study NCT00400868

Psycho-educational Joint protection education

Rheumatoid Arthritis

Comp 54 Adt Sen

Jul-06 Sep-09 University of Zurich; Zürcher Rheumastifung; Gertrude und Wolfgang Schrader-Dislich Stiftung; Swiss Ligue Against Rheumatism, Zurich, Switzerland

http://ClinicalTrials.gov/show/NCT00400868

Self-management, joint protection education and exercise in hand osteoarthritis: a randomised controlled trial in the community RCT ISRCTN33870549

Joint protection principles + usual care; Hand exercises + usual care; Joint protection + hand exercises + usual care; Usual care

Hand OA Comp 252 Adt Sen

Jun-06 May-08

Keele University http://www.controlled-trials.com/ISRCTN33870549/ISRCTN33870549

Device

Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome Phase II: RCT (active), Efficacy Study NCT01093209

Interferential Laser Therapy

Carpal Tunnel Syndrome; Neuropathic Pain

Rec 106 Adt Sen

Feb-10 Mar-11 Hospital Universitario Ramon y Cajal


Effect of orthoses in hand osteoarthritis RCT ISRCTN40357804

Orthosis; Exercise Carpo-metacarpal joint OA

Active 60 Adt Sen

Nov-08 Dec-10 Diakonhjemmet Hospital, Norway


Effect of Celliant Materials on Pain and Blood Oxygenation in Subjects With Chronic Elbow and Wrist Pain Prospective, Case Control Study NCT00688220

Celliant garment; Placebo celliant garment

Chronic Wrist Pain; Chronic Elbow Pain

Not yet Rec

80 Adt Sen

Dec-09 Dec-10 Southern California Institute for Research and Education; Hologenix, LLC


A Clinical Trial of Splinting for DeQuervain's Tenosynovitis Prospective, Cohort Study NCT00438191

Full time splint wear; As needed splint wear

DeQuervain's Tenosynovitis

Rec 80 Adt Sen

Dec-05 Dec-10 Massachusetts General Hospital


http://clinicaltrials.gov/show/NCT00400868

http://www.controlled-trials.com/ISRCTN33870549/ISRCTN33870549








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CMC Arthritis - Neoprene Vs. Thermoplast Short Opponens Splinting Prospective, Cohort Study NCT00438763

Neoprene splint; Thermoplast splint

Carpo-metacarpal Thumb Arthritis

Rec 70 Adt Sen

Dec-05 Dec-10 Massachusetts General Hospital


Effect of Assistive Technology in patients with Hand OsteoArthritis: A randomised, controlled trial RCT ISRCTN61534918

Assistive technology + education; education

Hand OA Comp 70 Adt Sen

Apr-08 Dec-09 Diakonhjemmet Hospital, Norway


CMC (Carpometacarpal) OA (Osteoarthritis) Thumb Splint Study Phase II: RCT (active), Efficacy Study NCT00705146

Comfort Cool thumb splint by North Coast Medical; Custom made thermoplastic & neoprene splint

Osteoarthritis, Carpo-metacarpal

Rec 48 Adt Sen

Apr-08 Dec-09 University of British Columbia; Vancouver Foundation


Drugs including biologics

Botulism Toxin Injection as a Treatment for Arthritis of the Basal Thumb Joint Phase IV: RCT (placebo), Safety/Efficacy Study NCT01045694

Botulinum Toxin Type A; Triamcinolone Acetonide; Lidocaine

Basilar Joint Arthritis; Basal Thumb Joint Arthritis; Trapeziometa-carpal Arthritis; Carpometa-carpal Arthritis

Not yet Rec

45 Adt Sen

Jan-10 Nov-13 University of Missouri-Columbia


Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo Phase III: RCT (placebo), Efficacy Study NCT01068405

Methotrexate; Placebo

Polyarthritis Not yet Rec

64 Adt Sen

Mar-10 Mar-12 Centre Hospitalier Universitaire de Nice


Comparison of oral prednisolone and oral indometacin in the treatment of acute gout-like arthritis: a multicentre double-blind randomised trial RCT ISRCTN45724113

Prednisolone; Indometacin

Gouty arthritis Active 400 Adt Sen

Jan-10 Dec-11 Health, Welfare and Food Bureau, Hong Kong










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A double blind, randomised, placebo controlled, multicentre trial of Anti-Tumour Necrotising Factor alpha (Anti-TNFα) chimeric monoclonal antibody (infliximab, Remicade®) in combination with methotrexate in patients with very early inflammatory arthritis RCT ISRCTN21272423

Symptomatic therapy + methotrexate + infliximab; Symtomatic therapy + methotrexate + placebo; Symptomatic therapy + placebo

Early arthritis (hand or foot involvement)

Active 200 Adt Sen

Sep-07 Sep-11 Medical Unviersity of Vienna, Austria


Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis RCT (active), Safety/Efficacy Study NCT00685880

Prolotherapy (10% dextrose solution); Corticosteroid solution

Thumb Carpo-metacarpal Joint Osteoarthritis

Rec 40 Adt Sen

May-08 Jul-11 Mayo Clinic http://ClinicalTrials.gov/show/NCT00685880

The efficacy of Trigger Finger treatment: a randomised, controlled, prospective clinical multicenter trial. RCT (active) NTR1135

Tramcinolone acetonide A-10; „open‟ surgery

Trigger finger Active 490 Adt Sen

Jan-08 Jan-11 University Medical Centre Utrecht


Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients Randomized, Crossover Assignment, Pharmacodynamics Study NCT00830050

Naproxen; Placebo Osteoarthritis Not yet Rec

24 Adt Sen

F-

only

May-10 Dec-10 Pfizer; King's College London


Efficacy Study of an Anti-Tumor Necrosis Factor (TNF) Alpha Agent in Patients With Hand Osteoarthritis Phase III: RCT (placebo), Efficacy Study NCT00597623

Adalimumab (Humira®); Placebo

Hand Osteoarthritis

Active, NR

84 Adt Sen

Jan-08 Dec-10 Assistance Publique Hôpitaux de Paris; Abbott


Corticosteroid Injection for Common Upper Extremity Problems RCT (placebo), Efficacy Study NCT00438672

Dexamethasone Injection; Placebo Injection

Lateral Elbow Pain; deQuervain's Tendonitis; CMC Arthritis

Rec 213 Adt Sen

Apr-03 Oct-10 Massachusetts General Hospital










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A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb Phase III: RCT NCT00398866

Synvisc (Hylan G-F20; hyaluronan injection); Bupivicaine (local anesthesia injection); Kenalog (triamcinolone; corticosteroid injection)

Osteoarthritis Rec 213 Adt Sen

Aug-06 Aug-10 Hospital for Special Surgery, New York; Genzyme


Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome Phase II: Single Group Assignment, Safety/Efficacy Study NCT00991068

Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch

Carpal Tunnel Syndrome

Active, NR

20 Adt Sen

Sep-09 Apr-10 ZARS Pharma Inc. http://ClinicalTrials.gov/show/NCT00991068

Study Comparing One Versus Two Cortisone Injections for Trigger Finger Parallel Assignment , Efficacy Study NCT00951236

One cortisone injection; Two cortisone Injections

Stenosing Tenosynovitis; Trigger Finger

Rec 392 Adt Sen

May-09 ? Mar-10

Rothman Institute Orthopaedics


A randomized, double blind, placebo-controlled trial to evaluate the clinical efficacy and the structure modifying properties of etanercept 50/25 mg sc weekly in patients with erosive OA of the interphalangeal finger joints. RCT (placebo) NTR1192

Etanercept 50mg; Etanercept 25mg

OA; Erosive inflammatory hand

Active 90 Adt Sen

Mar-08 Mar-10 Leiden University Medical Center


Safety and Efficacy of Lidoderm (Lidocaine Patch 5%) in Treating Moderate to Severe Pain Associated With Carpal Tunnel Syndrome Phase III: RCT (placebo), Safety/Efficacy Study NCT00266214

Lidocaine patch 5% Carpal Tunnel Syndrome

Term 310 Adt Sen

Nov-05 ? Feb-10

Endo Pharmaceuticals


Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand Phase IV: RCT (placebo), Safety/Efficacy Study NCT00291499

Chondroitin 4&6 sulfate (Condrosulf); Placebo

Osteoarthrosis Active, NR

160 Adt Sen

Jun-05 Jan-10 IBSA Institut Biochimique SA









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An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study Non-Randomized, Parallel Assignment, Safety/Efficacy Study NCT00198029

Synvisc (hylan G-F20)

Carpo-metacarpal Osteoarthritis

Rec 20 Adt Sen

Oct-04 Dec-09 Hospital for Special Surgery, New York; Genzyme; National Institutes of Health (NIH)


Study of Non Inferiority Bi-Profenid® 200mg Versus Bi-Profenid® 300mg Among Patients Presenting of the Post-traumatic or Rheumatologic Acute Affections of the Locomotor Apparatus (BIPROPAIN) Phase III: RCT (dose comparison), Safety/Efficacy Study NCT00810121

Ketoprofen 100 mg; Ketoprofen

Pain Comp 409 Adt Nov-08 Jun-09 Sanofi-Aventis http://ClinicalTrials.gov/show/NCT00810121

Effect of Diacerein on Hand Osteoarthritis Phase IV: RCT (placebo), Safety/Efficacy Study NCT00685542

Diacerein; Placebo Osteoarthritis Rec 86 Adt Sen

Jun-08 Jun-09 Seoul National University Hospital; Myungmoon Pharm. Co.


A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb Phase I: Randomized, Crossover Assignment, Efficacy Study NCT00743587

Oxycodone; Tramadol; Naproxen; Placebo

Osteoarthritis Thumbs

Comp 36 Adt Sen

Sep-08 Mar-09 Pfizer http://ClinicalTrials.gov/show/NCT00743587

Study to Evaluate the Efficacy of Adalimumab in Patients With Erosive Osteoarthritis of the Interphalangeal Finger Joints Phase II: RCT (placebo), Efficacy Study NCT00296894

Adalimumab (40 mg sc every other week); Placebo

Erosive Osteo-Arthritis

Comp 60 Adt Sen

May-06 Feb-09 University Hospital, Ghent







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A Phase 3, Double-Blind, Randomized, Placebo Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren‟s Contracture Followed by an Open-Label Extension Phase RCT (placebo), Efficacy Study ACTRN12607000216415

AA4500 (Clostridial collagenase); Placebo

Dupuytren‟s contracture

Comp 60 Adt Sen

Jul-07 > Jul-08

Auxilium Pharmaceuticals, Inc; Novotech (Australia) Pty Ltd.

http://www.anzctr.org.au/trial_view.aspx?ID=81966

Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis Phase II/III; RCT (placebo), Safety/Efficacy Study NCT00640939

Diclofenac sodium; Matching Placebo

DeQuervain's Tenosynovitis of the Wrist; and other conditions

1

Comp 308 Adt Sen

Dec-07 Jun-08 Cerimon Pharmaceuticals; PPD


Other including CAM therapies

Mild Carpal Tunnel Syndrome Randomized, Parallel Assignment NCT00981565

Open carpal tunnel release; Night-cast


Rec 88 Adt Sep-09 Jan-12 North Carelia Central Hospital


Stop-rule management in patients with sub-acute chronic pain (WRUEP): a randomized controlled and replicated single case experimental ABCD design. RCT (active) NTR1517

Stop-rule management; Regular rehabilitation

Repetitive strain injury; non-specific work-related upper limb disorders (shoulder, arm elbow, neck, wrist, hand)

Active 12 Adt Nov-08 Nov-10 University Maastricht http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1517

Mechanisms of Neural Mobilization in the Treatment of Chronic Pain Phase I/II: RCT (placebo), Efficacy Study NCT00929123

Neural mobilization; Sham neural mobilization; Healthy controls


Active, NR

60 Adt Sen

May-07 Oct-09 National Center for Complementary and Alternative Medicine (NCCAM)


1 Rotator Cuff Tendonitis; Bicipital Tendonitis; Subdeltoid Bursitis of the Shoulder; Subacromial Bursitis of the Shoulder; Medial Epicondylitis of the Elbow; Lateral Epicondylitis of the Elbow








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Multidisciplinary versus traditional outpatient management of osteoarthritis: a randomised, controlled trial in Norway RCT ISRCTN25778426

Novel multidisciplinary intervention; Usual care

OA, hand; OA, hip; OA, knee; OA, generalised

Comp 400 Adt Sen

Aug-06 Aug-09 National Resource Center for Rehabilitation in Rheumatology, Norway


Hyperthermia As A Conservative Treatment For Carpal Tunnel Syndrome. A Randomized "Sham" Controlled Trial RCT (placebo), Safety/Efficacy Study NCT00988923

Hyperthermia; No intervention


Comp 34 Adt Sen

Oct-07 Sep-08 Catholic University of the Sacred Heart


Carpal Tunnel Syndrome: Diagnosis and Treatment Trial RCT (active), Safety/Efficacy Study NCT00032227

Early Carpal Tunnel Release; Non-surgical interventions; MR Nerve Imaging for CTS


Comp 116 Adt Sen

Aug-02 Apr-08 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Miscellaneous observational studies

The course of hand pain and hand problems in community dwelling adults aged 50 years and over in North Staffordshire; 54 month follow-up of the clinical assessment study of the hand (CAS-HA) Cohort study UKCRN ID 6912

Hand pain; hand problems

Active 506 Adt Sen

N/K Jul-10 Keele University http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=6912





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A2: ELBOW PAIN

Title Phases: trial design (control) CT ID


Start Date

End Date

Sponsors URL


Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis Phase IV: Randomized, Factorial Assignment, Efficacy Study NCT00826462

Physiotherapy + Triamcinolone + Lidocaine + Naproxene; Physiotherapy + Placebo + Lidocaine + Naproxene; Naproxene

Tennis Elbow; Epicondylitis, Lateral Humeral

Rec 174 Adt Sen

Mar-09 Mar-13 University of Oslo; Allmenn-medisinsk forskningsfond, Norway


Conservative Treatment for Tennis Elbow RCT (active) ISRCTN65048343

Exercise class; Individual physiotherapy; Supervised home-class

Tennis elbow Comp 90 Adt Jul-06 Oct-09 Department of Health, UK


The efficacy of combining physiotherapy and corticosteroid injection in the treatment of tennis elbow: a randomised control trial RCT (placebo) ACTRN12609000051246

Physiotherapy + Corticosteroid injection; Physiotherapy + saline injection; Corticosteroid injection; saline injection

Tennis elbow N/K 132 Adt Sen

Aug-08 > Aug-09

University of Queensland; Griffith University, Australia


Intra-articular Glucocorticoid Treatment of the Elbow RCT (active), Efficacy Study NCT00972530

Immobilisation in a triangular sling following intra-articular injection


Comp 90 ChildAdt Sen

Jan-06 Dec-08 Department of Research and Development, County Council of Gavleborg and Uppsala University; Meda AB








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Tennis Elbow Trial Randomized, Parallel Assignment, Efficacy Study NCT00888225

Eccentric exercise; Concentric exercise

Lateral Epicondylitis

Comp 205 Adt Sen

Oct-03 Dec-08 Uppsala University; The Swedish Research Council; Amersham Foundation; Uppsala County Council, Sweden


Device

Effect of Celliant Materials on Pain and Blood Oxygenation in Subjects With Chronic Elbow and Wrist Pain Observational: Prospective, Case Control NCT00688220

Celliant garment; Placebo celliant garment

Chronic Wrist Pain; Chronic Elbow Pain

Not yet Rec

80 Adt Sen

Dec-09 Dec-10 Southern California Institute for Research and Education; Hologenix, LLC


Use of TPD Heat Lamp for Tennis Elbow Pain - a Randomized-Controlled Trial Phase II/III: RCT (placebo), Efficacy Study NCT00725023

TDP© Lamp; Dummy TDP© Lamp


Active, NR

116 Adt Aug-08 Oct-09 Queen's University http://ClinicalTrials.gov/show/NCT00725023

The efficacy of a specific tennis elbow brace („Go-Strap brace‟) compared to a standard counterforce brace in participants with tennis elbow RCT (active), Efficacy study ACTRN12609000354280

“Go-Strap brace”; Standard counterforce brace

Tennis elbow N/K 35 Adt Jun-09 > Jun-09

Griffith University, Australia


Study of LED Phototherapy for Musculoligamentous Lesions RCT (placebo), Efficacy Study NCT00382941

Red and near infrared LED phototherapy device

Tendinopathy; Sprains and Strains; Muscle Spasm; Epicondylitis; Fasciitis

Comp ChildAdt Sen

? Dec-08

Hermano Miguel Foundation








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Treatment of Lateral Epicondylitis: Platelet Rich Plasma Versus Steroid Versus Saline Solution RCT (active), Safety/Efficacy Study NCT01109446

Platelet Rich Plasma; Isotonic Saline Solutions; Triamcinolon-acetonid


Rec 60 Adt Sen

Jan-09 Oct-11 University of Aarhus http://ClinicalTrials.gov/show/NCT01109446

Botulinum Toxin Versus Active Strength Training in the Treatment of Lateral Epicondylitis RCT (active), Efficacy Study NCT00930709

Botulinum toxin type A (Botox®, Allergan); Behavioral: Active strength training and stretching

Epicondylitis, Lateral Humeral; Tennis Elbow

Rec 120 Adult Mar-09 Aug-11 Seinajoki Central Hospital


Corticosteroid Injection for Common Upper Extremity Problems RCT (placebo), Efficacy Study NCT00438672

Dexamethasone Injection; Placebo Injection

Lateral Elbow Pain; deQuervain's Tendonitis; CMC Arthritis

Rec 213 Adt Sen

Apr-03 Oct-10 Massachusetts General Hospital


Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment Phase III: RCT (placebo), Efficacy Study NCT00437762

Botulinum Toxin A Injection; Placebo injection

Tennis Elbow Rec 60 Adt Sen

Apr-07 Dec-09 University Hospital, Bordeaux; Ipsen


Study to Compare the Pharmacokinetics of a Dexamethasone Iontophoretic Patch to a Dexamethasone Injection Phase I: Randomized, Crossover Assignment, Pharmacokinetics Study NCT00895076

Dexamethasone injection; DexamethasoneIontophoretic Patch

Lateral Epicondylitis (Tennis Elbow)

Active, NR

12 Adult May-09

May-09

Travanti Pharma Inc.; Cetero Research


Dexamethasone Iontophoretic Patch for the Treatment of Pain Associated With Lateral Epicondylitis Phase II: RCT (placebo), Safety/Efficacy Study NCT00794976

Dexamethasone Iontophoretic Patch (low dose); Dexamethasone Iontophoretic Patch (high dose); Dexamethasone Passive Patch; Placebo Patch

Lateral Epicondylitis; (Tennis Elbow)

Comp 200 Adt Sen

Oct-08 May-09

Travanti Pharma Inc.; ResearchPoint








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Platelet-rich-plasma Treating Tennis Elbow RCT (active), Safety/Efficacy Study NCT00757289

PRP Injection; Corticosteroid Injection

Pain; Tennis elbow

Comp 100 Adt Sen

Aug-07 Jan-09 Biomet, Inc. http://ClinicalTrials.gov/show/NCT00757289

Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis Phase III: RCT (placebo), Safety/Efficacy Study NCT00426985

Ketoprofen Topical Patch 20%

Tendonitis; Bursitis

Term 330 Adt Sen

Jan-07 Oct-08 Endo Pharmaceuticals


Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis Phase II/III: RCT (placebo), Safety/Efficacy Study NCT00640939

Diclofenac sodium; Placebo

Upper limb conditions

2

including Medial Epicondylitis of the Elbow; Lateral Epicondylitis of the Elbow

Comp 308 Adt Sen



A Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis Phase II/III: RCT (historical), Efficacy Study NCT00947765

Autologous blood injection; Local corticosteroid injection

Tennis Elbow; Epicondylitis, Lateral Humeral

Comp 60 Child Adt Sen

Jan-07 Jun-08 Jawaharlal Nehru Medical College


Doxycycline for Lateral Epicondylalgia - RCT RCT (placebo), Efficacy Study NCT00631501

Doxycycline; Placebo

Lateral Epicondylalgia (Tennis Elbow)

Rec 34 Adt ? Feb-08

Kaunas University of Medicine; University Hospital, Linkoeping



The Treatment and Advice for Tennis Elbow study RCT (active) ISRCTN87141084

Patient-controlled TENS + usual care; usual care

Tennis elbow Active 240 Adt Sen

May-05

Jun-11 Keele University http://www.controlled-trials.com/ISRCTN87141084

2 Rotator Cuff Tendonitis; Bicipital Tendonitis; Subdeltoid Bursitis of the Shoulder; Subacromial Bursitis of the Shoulder; DeQuervain's Tenosynovitis of the Wrist








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Active 12 Adt Nov-08 Nov-10 University Maastricht http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1517

Prolotherapy for the Treatment of Chronic Lateral Epicondylitis Phase II/III: RCT (placebo), Efficacy Study NCT00674622

Prolotherapy; Placebo

Lateral Epicondylitis; Tennis Elbow

Rec 60 Adt Sep-07 Sep-10 University of Pittsburgh; National Center for Complementary and Alternative Medicine (NCCAM)


The effect of acupuncture on lateral elbow pain compared to laser: a randomised controlled pilot study. RCT (placebo) ACTRN12609000928213

Acupuncture; Sham acupuncture

Lateral elbow pain

N/K 24 Adt Oct-09 > Dec-09

University of Technology, Sydney


Influence of Microcurrent Parameters on Effectiveness in Treatment of Chronic Tennis Elbow Phase II/III: Non-randomized, Parallel Assignment (historical), Efficacy Study NCT00905736

Microcurrent treatment (controlled current); Micocurrent treatment (controlled voltage)

Tennis Elbow Active, NR

24 Adt Sen

Apr-09 Dec-09 University of Hertfordshire


Effectiveness of Microcurrent for Treatment of Tennis Elbow Phase II/III: RCT (historical), Efficacy Study NCT00817232

Microcurrent (Elexoma Medic)

Tennis Elbow Active, NR

24 Adt Sen

Dec-08 Dec-09 University of Hertfordshire


Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT) RCT (placebo), Efficacy Study NCT00435318

Iontophoresis Lateral Epicondylitis

Wtdwn 40 Adt Sen

Feb-07 Jan-09 Vanderbilt University http://ClinicalTrials.gov/show/NCT00435318









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A3: SHOULDER PAIN



Start Date

End Date

Sponsors URL


Operative Versus Non-operative Management of Subacromial Impingement Randomized, Parallel Assignment, Efficacy Study NCT00637013

Physical therapy; Surgery (Subacromial decompression)

Subacromial Impingement Syndrome

Rec 100 Adult Sen

Jun-08 Dec-15 Central Finland Hospital District; Academy of Finland; National Research and Development Centre for Welfare and Health


Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population Phase III: Single Group Assignment, Efficacy Study NCT01050972

Cognitive, Relaxation and Exercise Therapy

Migraine; Tension Type Headache; Cervical Pain; Shoulder pain

Rec 15000 Child Adt Sen

Jun-09 Nov-11 University of Turin, Italy; Fondazione CRT, Torino; Comune di Torino; Regione Piemonte


Physiotherapy for shoulder impingement syndrome RCT (active) ISRCTN86900354

Physiotherapy + home-based exercise; Standard exercise

Shoulder impingement syndrome

Active 90 Adt Sen

Mar-10 Sep-11 Physiotherapie-zentrum T.O. Kromer, Germany


Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome RCT (active), Efficacy Study NCT00633451

Manual Therapy and Exercise; Exercise Only

Shoulder Impingement Syndrome

Rec 100 Adt Sen

Feb-08 Jul-11 Proaxis Therapy; Virginia Commonwealth Uni.; Arcadia Uni.; National Athletic Training Association Research & Education Foundation


Subacromial Impingement - The Need of Arthroscopic Subacromial Decompression After Eccentric Physical Therapy Exercises Randomized, Parallel Assignment, Efficacy Study NCT01037673

Exercise program; Movement exercises


Rec 100 Adt Sen

Jan-08 Mar-11 Linkoeping University








20

Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome Phase II: Single Group Assignment, Efficacy Study NCT00632996

Rehabilitation Shoulder Impingement Syndrome

Rec 225 Adt Sen

Jan-08 Jan-11 Virginia Commonwealth University; National Athletic Trainers' Association REF; University of North Florida; Arcadia University


Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck RCT (dose comparison) Efficacy Study NCT01027390

Physical training exercise

MSK Disorders Invite 800 Adt Sen

Jan-10 Dec-10 University of Southern Denmark; National Research Centre for the Working Environment, Denmark; University of Copenhagen


Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy RCT (active), Efficacy Study NCT00782522

Eccentric training program; Traditional training program

Chronical Rotator Cuff Tendinopathy

Rec 90 Adt Apr-09 Dec-10 University Ghent; BOF


The Clinical Efficacy of Belting Stabilization for Shoulder Pain Phase I: RCT (placebo), Efficacy Study NCT00826293

Stabilization belt

Rotator Cuff Impingement Syndrome

Invite 64 Adt Jan-09 Dec-10 Sunnybrook Health Sciences Centre


Shoulder Training: Muscle Recruitment Patterns and the Effect of an Exercise Program Controlled trial (active), Efficacy Study NCT00774956

Exercise training program

Shoulder Impingement

Rec 60 Adt Sep-08 Dec-10 University Ghent http://ClinicalTrials.gov/show/NCT00774956

Physical activity to prevent deterioration in cleaners RCT ISRCTN96241850

Physical coordination training; Cognitive behavioural training; Health check

Shoulder pain; Neck pain

Active 400 Adt Aug-07 Dec-10 The Ministry of Culture Committee on Sports Research









21

Effect of Kettlebell Training on Musculoskeletal and Cardiovascular Health Randomized, Factorial Assignment NCT01076127

Ketllebell training; Control

MSK Disorders; Neck pain; Shoulder pain; Back pain

Active, NR

40 Adt Mar-10 Aug-10 National Research Centre for the Working Environment, Denmark


Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Industrial Workers Randomized, Factorial Assignment NCT01071980

Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck

Non-specific Pain of the Neck and Shoulder

Comp 522 Adt Jan-09 Feb-10 National Research Centre for the Working Environment, Denmark; University of Copenhagen; University of Southern Denmark


Operative or Conservative Treatment for Subacromial Impingment Syndrome? Phase II: RCT (placebo), Efficacy Study NCT00428870

Supervised exercise therapy; Arthroscopic subacromial decompression; diagnostic arthroscopy


Rec 210 Adult Oct-05 Dec-09 Helsinki University http://ClinicalTrials.gov/show/NCT00428870

Shoulder Injury Prevention Program in Swimmers Phase II: RCT (active), Efficacy Study NCT00998777

Shoulder Strengthening

Shoulder Injury Active, NR

48 Adt Sep-09 Nov-09 University of North Carolina, Chapel Hill


The Efficacy of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Working Community Phase III: RCT (active), Efficacy Study NCT00551980

Cognitive, Relaxation, and Exercise Therapy

Migraine; Tension Type Headache; Cervical Pain; Shoulder pain


Oct-07 Nov-09 University of Turin, Italy; Compagnia di San Paolo; Comune di Torino; CPO Piemonte; Regione Piemonte


Exercise therapy for shoulder impingement syndrome RCT (active) ISRCTN76701121

Open kinetic chain strengthening; Closed kinetic chain strengthening; range of motion

Chronic shoulder impingement syndrome

Comp 169 N/K Oct-05 Oct-09 Department of Health, UK









22

The Shoulder Window of Opportunity Study RCT (active) ISRCTN25817033

Subacromial corticosteroid injection with physiotherapy; physiotherapy alone.

Unilateral shoulder pain; subacromial impingement syndrome

Comp 220 Adt Sen

Mar-06 Mar-09 West Yorkshire Primary Care Research and Development Unit, UK


The effect of neck coordination training on sensorimotor function, symptoms and self-rated health and functioning for non-specific neck-shoulder pain RCT ISRCTN92199001

Neck coordination; Strengthening training; Massage; No intervention.

Chronic non-specific neck-shoulder pain

Comp 180 Adt Mar-08 Dec-08 Swedish council for Working Life and Social Research, Sweden


Treatment of Myofascial Trigger Points in common shoulder disorders by physical therapy: a randomised controlled trial RCT ISRCTN75722066

Physical therapy + exercise + advice; Wait and see

MSK Chronic shoulder disorders

Comp 104 Adt Sep-07 Sep-08 http://www.controlled-trials.com/ISRCTN75722066

Effects of Eccentric Training for Shoulder Abductors in Subjects With Shoulder Impingement Syndrome Single Group Assignment, Efficacy Study NCT01090271

Isokinetic eccentric training


Comp 25 Adt Oct-07 Jun-08 Universidade Federal de Sao Carlos


Device

Transcutaneous Pulse Radiofrequency (PRF) Treatment For Shoulder Pain RCT (placebo) ACTRN12610000171011

Transcutaneous Pulse Radiofrequency (PRF); Inactive PRF

Shoulder pain Not yet Rec

50 Adt Sen

Apr-10 > Oct-10

Frankston Hospital, Australia


Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain Phase II: RCT (placebo), Efficacy Study NCT00587626

InterX 5000 Treatment; Inactive InterX 5000

Neck Pain; Shoulder Pain; Cervical Pain

Rec 80 Adt Sen

Aug-07 Dec-09 Hamilton Health Sciences; Canadian Memorial Chiropractic College; Neuro Resource Group












23

Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Pain, Responders and Non-Responders? Observational: Prospective, Cohort Study NCT00885859

TENStemeco Schwa Medico

Neck Pain; Lower Back Pain; Shoulder Pain

Not yet Rec

62 Adt Sen

Jun-09 Dec-09 Maastricht University Medical Center


Efficacy of Interferential Laser Therapy in Shoulder Pain Phase II: RCT (active), Efficacy Study NCT00694538

Interferential Laser therapy

Shoulder MSK Disorders

Comp 200 Adt Sen

Jan-08 Nov-09 Hospital Universitario Ramon y Cajal


Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections RCT (active), Efficacy Study NCT00480675

Trochanteric bursa injection under fluoroscopy with depomedrol and bupivacaine; Trochanteric bursa injection with depomedrol and bupivacaine

Bursitis Comp 65 Adt Sen

Mar-07 May-08 Johns Hopkins University



Effectiveness of an Oxygen-nitrous Oxide Mixture During Physical Therapy for Frozen Shoulder Phase IV: RCT (placebo), Efficacy Study NCT01087229

Equimolar oxygen-nitrous oxide mixture

Adhesive Capsulitis

Rec 80 Adt Sen

Mar-10 Apr-12 Centre Hospitalier Universitaire de Nīmes


Capsular and Intra-Articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial RCT (placebo) NCT00840229

Lidocaine; triamcinolone

Adhesive Capsulitis

Not yet Rec

150 Adt Sen

Feb-09 Dec-11 Rikshospitalet HF http://ClinicalTrials.gov/show/NCT00840229

Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis RCT (placebo), Efficacy Study NCT00983177

Colchicine; lactose Calcific Tendonitis

Not yet Rec

80 Adt Sen

Mar-10 Oct-11 Bnai Zion Medical Center








24

Etoricoxib in Acute Soft Tissue Rheumatism Affecting the Shoulder Phase III: RCT (active), Safety/Efficacy Study NCT00876317

Etoricoxib 60 mg; Etoricoxib 90 mg

Soft Tissue Injuries of the Shoulder; Tenosynovitis and Bursitis Affecting the Shoulder

Not yet Rec

300 Adt Sen

Aug-09 Oct-11 Clinica Virgen Milagrosa


Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder RCT (dose comparison), Safety/Efficacy Study NCT00914836

Betamethasone Sodium Phosphate 1cc ; Betamethasone Sodium Phosphate 2cc


Not yet Rec

100 Adt Sen

Jun-09 May-11 HaEmek Medical Center, Israel


Timed Release Tablet Prednisone in Polymyalgia Rheumatica Phase II/III: RCT (dose comparison), Efficacy Study NCT00836810

Timed Release Tablet Prednisone; Prednisolone

Polymyalgia Rheumatica

Rec 24 Adt Sen

Oct-09 Feb-11 University Hospitals Bristol NHS Trust


Study Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome Phase II: Single Group Assignment, Safety/Efficacy Study NCT01055444

Heated lidocaine and tetracaine topical patch


Rec 20 Adt Sen

Mar-10 Aug-10 ZARS Pharma Inc. http://ClinicalTrials.gov/show/NCT01055444

Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Glenohumeral Osteoarthritis (OA) Non-Randomized (active), Safety/Efficacy Study NCT00969501

EUFLEXXA Osteoarthritis Active, NR

25 Adt Sen

Aug-09 Jul-10 Georgia Institute for Clinical Research, LLC; Ferring Pharmaceuticals


ORTHOVISC Shoulder RCT Phase III: RCT (active), Safety/Efficacy Study NCT00436969

ORTHOVISC Glenohumeral Osteoarthritis

Active, NR

270 Adt Sen

Dec-06 Aug-10 DePuy Mitek http://ClinicalTrials.gov/show/NCT00436969







25

A comparison of the efficacy of corticosteroid and anaesthetic injection into the glenohumeral joint with and without hydrodilatation in patients with frozen shoulders. RCT (active), Efficacy Study ACTRN12610000187044

Corticosteriod and local anaesthetic injection with hydrolation; Corticosteriod and local anaesthetic injection without hydrolation

Frozen Shoulder

Not yet Rec

100 Adt Sen

Mar-10 > Jun-10

Monash Medical Centre, Australia


Hyaluronic acid versus corticosteroids compared to a placebo in subacromial injections for shoulder cuff impingement RCT (placebo) ISRCTN51511455

Lidocaine + hyaluronic acid; Lidocaine + Triamcinoloni-acetonidum; Lidocaine + saline

Shoulder disorders; complaints of shoulder; painful arc

Comp 159 Adt Sen

Oct-04 Mar-10 Care and Public Health Research Institute, The Netherlands


SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder Phase III: RCT (placebo), Safety/Efficacy Study NCT00479687

SUPARTZ; Saline Glenohumeral Osteoarthritis of the Shoulder

Active, NR

300 Adt Sen

May-07 Sep-09 Smith & Nephew, Inc.; Seikagaku Corporation


HKT-500 in Adult Patients With Shoulder Pain Phase III: RCT (placebo), Safety/Efficacy Study NCT00680472

HKT-500 & Ketoprofen Topical Patch; Placebo

Pain Comp 368 Adt Sen

Apr-08 Oct-08 Hisamitsu Pharmaceutical Co., Inc.





Term 330 Adt Sen






26

Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis Phase II/III: RCT (placebo), Safety/Efficacy Study NCT00640939

Diclofenac sodium; Matching Placebo

Upper limb conditions

3

including Rotator Cuff Tendonitis; Bicipital Tendonitis; Subdeltoid Bursitis of the Shoulder; Subacromial Bursitis of the Shoulder

Comp 308 Adt Sen




Efficacy of Electrotherapy in Subacromial Impingement Syndrome RCT (placebo), Efficacy Study NCT01073956

Medium-wave 448 kHz therapy; Ultrasonic therapy; Inactive electrotherapy


Rec 492 Adt Sen

Feb-10 Jun-12 Fundacio Espai Salut


Ultrasound Guided Diagnostic Cervical Medial Branch Block Single Group Assignment, Safety/Efficacy Study NCT00896688

Cervical medial branch blocks using the Quincke spinal needle

Facet Joint Disease; Neck Pain; Shoulder pain

Rec 25 Adt Jan-09 Jan-11 Hamilton Health Sciences


MedlinePlus Health Prescriptions: Developing a Pragmatic Approach for Clinic Use RCT (active) NCT01050465

Health information prescription

Range of conditions

4

including Back Pain; Fibromyalgia; Knee Pain; Osteoarthritis; Senile Osteoporosis; and Shoulder Pain

Invite 728 Adt Sen

May-09 Dec-10 University of Missouri-Columbia; National Library of Medicine (NLM)


3 Medial Epicondylitis of the Elbow; Lateral Epicondylitis of the Elbow; DeQuervain's Tenosynovitis of the Wrist 4 Acne Vulgaris; Allergic Rhinitis; Anxiety; Asthma; Prostatic Hyperplasia; Bursitis; Chronic Obstructive Pulmonary Disease; Cough; Coronary Artery Disease; Depression; Diabetes Mellitus;

Diarrhea; Gastroesophageal Reflux; Headache; HIV Infections; Hypothyroidism; Hyperlipidemia; Hypertension; Influenza; Sleep Initiation and Maintenance Disorders; Irritable Bowel Syndrome;





27




Active 12 Adt Nov-08 Nov-10 University Maastricht


Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension? Non-Randomized, Parallel Assignment, Efficacy Study NCT00992927

Capsule-preserving Intra-articular Hydraulic Distension; Capsule-rupturing Intra-articular Hydraulic Distension

Adhesive Capsulitis

Rec 50 Adt Sen

Mar-08 Feb-10 Seoul National University Hospital


Diaphragmatic Movement Before and After Stellate Gaglion Block : A Ultrasonographic Study Phase IV Primary Purpose: Treatment NCT01054378

M-mode ultrasonography

Head Pain; Neck Pain; Shoulder Pain; Arm Pain; Neural Sensory Hearing Loss

Rec 60 Adt N/K ? Jan-10

Yonsei University http://ClinicalTrials.gov/show/NCT01054378

Effectiveness in the treatment of Subacromial Impingement Syndrome by dry needling of active myofascial trigger points: a randomised controlled trial Observational (on diagnosis); RCT active ISRCTN30907460

Dry needling + Physiotherapy; Physiotherapy alone

Rotator Cuff Tendonitis; Subacromial Impingement Syndrome; Shoulder pain

Comp 132 Adt Sen

Oct-08 Oct-09 Aragones Institute of Health Science, Spain


Efficacy Study of Fine Needle Technique on Calcific Tendinitis Phase II: RCT (active), Efficacy Study NCT00506038

Fine needle technique

Tendinitis Term 40 Adt Sen

N/K ? Jun-09

Hadassah Medical Organization


Migraine Disorders; Obesity; Obstructive Sleep Apnea; Colonoscopy; Mammography; Sinusitis; Smoking Cessation; Tobacco Use Cessation; Menopause; Urinary Incontinence; Urinary Tract Infection; Vaccination; Vaginitis; Vertigo








28

Development of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation Phase II: Single Group Assignment, Efficacy Study NCT00835302

Cervicothoracic manipulation

Shoulder Pain Active, NR

80 Adt Oct-06 Mar-09 University of Colorado, Denver


Ultrasound Evaluation of the Rotator Cable and Associated Structures. NCT00743600

Ultrasound Shoulder Pain Rec N/K Adt Sen

Sep-05 ? Feb-09

University of Michigan


Study of the Effect of Neck Treatment on Shoulder Impingement Phase I: Randomized, Parallel Assignment, Efficacy Study NCT00764764

Shoulder treatment; Shoulder and cervical treatment

Shoulder Impingement; Shoulder Pain; Rotator Cuff Tendinitis; Cervical Degenerative Joint Disease

Term 30 Adt Sen

May-08 Dec-08 CAMC Health System


Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS Phase III: RCT (active), Efficacy Study NCT00653081

Supervised Exercises; Radial Extracorporeal Shockwave Therapy

Shoulder Pain Active, NR

104 Adt Sen

Jul-06 Dec-08 Ullevaal University Hospital; South Eastern Area Health Service; University of Oslo


Integrating Targeted MedlinePlus Health Prescriptions Into Clinic Practice Workflow Non-Randomized (Historical), Efficacy Study NCT00634608

Health Information Prescription - MedlinePlus link

Various conditions including

5 Back

Pain; Osteoporosis (Senile) and Shoulder Pain

Active, NR

400 Adt Sen

Feb-08 Oct-08 University of Missouri-Columbia; National Library of Medicine (NLM)


5 Allergic Rhinitis; Asthma; Benign Prostatic Hypertrophy; Bursitis; Depression; Anxiety; Diabetes Mellitus; Esophageal Reflux; HIV Infections; Hyperlipidemia; Hypertension; Insomnia; Irritable

Bowel Syndrome; Obesity; Sinusitis; Symptomatic Menopause; Urinary Incontinence; Urinary Tract Infection; Vaginitis






29


Mechanical Load on the Shoulders While Carrying a Backpack- Towards a Knowledge-Based Backpack Design Prospective, Case-Only study NCT01066975

Healthy; Strain Not yet Rec

5 Adt

M-only

Feb-10 Apr-11 Sheba Medical Center; Tel Aviv University


Prevalence of Impaired Glucose Tolerance (IGT) in Patients With Frozen Shoulder Cross-sectional, Case-Crossover study NCT00926094

Frozen Shoulder; Impairment Glucose Tolerance

Rec 50 Adt Apr-09 Jun-10 Hadassah Medical Organization


Biopsychosocial Factors' Influence on Shoulder Pain Prospective NCT00187863

Shoulder pain; Pain perception; Pain Assessment

Active, NR

350 Adt Sen

May-05 ? May-08

University of Florida http://ClinicalTrials.gov/show/NCT00187863

A4: NECK PAIN



Start Date

End Date

Sponsors URL


The Value of Traction in the Treatment of Cervical Radiculopathy Phase III: RCT (active) NCT00979108

Physical therapy rehabilitation

Radiculopathy; Neck Pain; Spinal Diseases; MSK Diseases; Neuromuscular Diseases; Intervertebral Disk Displacement

Rec 192 Adt Sen

Jul-09 Jul-12 Intermountain Health Care, Inc.; University of Utah; Wilford Hall Medical Center; Empi, A DJO Company






30

Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population Phase III: Single Group Assignment, Efficacy Study NCT01050972

Cognitive, Relaxation and Exercise Therapy

Migraine; Tension Type Headache; Cervical Pain


Jun-09 Nov-11 University of Turin, Italy; Fondazione CRT, Torino; Comune di Torino; Regione Piemonte


Neck Pain in Danish Military Pilots and Flight Crew Randomized, Parallel Assignment NCT00812903

Exercise; no intervention

Neck Pain Rec 150 Adt Sen

Mar-09 Jul-11 University of Southern Denmark; Odense University Hospital; Danish Defence; Royal Danish Air Force


Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck RCT (dose comparison), Efficacy Study NCT01027390

Physical training exercise

MSK Disorders; Neck pain; Shoulder pain

Invite 800 Adt Sen

Jan-10 Dec-10 University of Southern Denmark; National Research Centre for the Working Environment, Denmark; University of Copenhagen


Physical activity to prevent deterioration in cleaners RCT ISRCTN96241850

Physical coordination training; Cognitive behavioural training; Health check

Shoulder pain; Neck pain

Active 400 Adt Aug-07 Dec-10 The Ministry of Culture Committee on Sports Research




MSK Disorders; Neck pain; Shoulder pain; Back pain

Active, NR



Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Industrial Workers Randomized, Factorial Assignment NCT01071980

Work Place Adjusted Intelligent Physical Exercise Reducing MSK Pain in Shoulder and Neck

Non-specific Pain of the Neck and Shoulder

Comp 522 Adt Jan-09 Feb-10 National Research Centre for the Working Environment, Denmark; University of Copenhagen; University of Southern Denmark









31

Effect of Neck Strength Training on Health-related Quality of Life in Females With Neck Pain Randomized, Crossover Assignment NCT01057836

Neck endurance training; Stretching

Neck Pain Comp 180 Adt

F -only

N/K ? Jan-10

Jyväskylä Central Hospital


The efficacy of a cognitive and physical intervention to reduce head & muscle pain in a working community Phase III: RCT, Efficacy Study NCT00551980

Cognitive, Relaxation and Exercise Therapy; No intervention

Migraine; Tension Type Headache; Cervical Pain


Oct-07 Nov-09 University of Turin, Italy


Qigong and Exercise for Neck Pain in Adults (QENA) Randomized, Parallel Assignment NCT00615732

Qigong; Exercise therapy

Chronic Neck Pain

Comp 120 Adt Mar-08 Oct-09 Charite University, Berlin, Germany


The effectiveness of Global Postural Reeducation Method (GPR) and conventional kinesiotherapy on pain, quality of life and functional disability in subjects with chronic spine pain. RCT (active) ACTRN12609000962235

Global Postural re-education; Kinesiology

Spine, Chronic pain; Chronic neck pain; chronic low back pain

Active NR

150 Adt Oct-07 > Aug-09

Universidade Federal de Sao Paulo


A randomised clinical trial to determine the effects on the neck range of movement of SNAGs versus exercise RCT ISRCTN39100909

Sustained natural apophysical glide (SNAG); Exercise

MSK Diseases; Neck problems

Comp 40 N/K Feb-07 Aug-09 Department of Health, UK


The effect of neck coordination training on sensorimotor function, symptoms and self-rated health and functioning for non-specific neck-shoulder pain RCT ISRCTN92199001

Neck coordination; Strengthening training; Massage; No intervention.

Chronic non-specific neck-shoulder pain

Comp 180 Adt Mar-08 Dec-08 Swedish council for Working Life and Social Research, Sweden


Participatory ergonomics for the primary prevention of back and neck pain: a cost-effectiveness study RCT (placebo) ISRCTN27472278

Participative ergonomic program

Back pain; Neck pain; prevention

Comp 3668 Adt Sen

Oct-07 Oct-08 VU University Medical Centre, The Netherlands













32

Device

Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain Phase II: RCT (placebo), Efficacy Study NCT00587626

InterX 5000 Treatment; Inactive InterX 5000

Neck Pain; Shoulder Pain; Cervical Pain

Rec 80 Adt Sen

Aug-07 Dec-09 Hamilton Health Sciences; Canadian Memorial Chiropractic College; Neuro Resource Group


Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Pain, Responders and Non-Responders? Observational: Prospective, Cohort study NCT00885859

TENStemeco Schwa Medico


Not yet Rec

62 Adt Sen

Jun-09 Dec-09 Maastricht University Medical Center


Electroacupuncture for Chronic Neck Pain Phase II: RCT (placebo), Efficacy Study NCT00826215

Electro-acupuncture; Sham laser acupuncture

Neck Pain Active, NR

200 Adt Sen

Mar-07 Feb-09 Hong Kong Baptist University; The Hong Kong Polytechnic University



Trial to Evaluate the Efficacy of Topical Capsaicin to Reduce Pain and Improve Health-related Quality of Life in Adults With Chronic Myofascial Neck Pain Phase II: RCT (placebo), Efficacy Study NCT00795106

Capsaicin; Placebo Myofascial Pain Syndrome

Not yet Rec

60 Adt Sen

Nov-09 Nov-10 Stamford Hospital http://ClinicalTrials.gov/show/NCT00795106

Pregabalin and Radicular Pain Study (PARPS) Phase IV: Single Group Assignment NCT01061697

Pregabalin Cervical Spondylosis; Cervical Spondylotic Myelopathy; Cervical Spondylotic Radiculopathy

Active, NR

50 Adt Sen

Jan-08 Apr-10 Singapore General Hospital; Pfizer







33

Oral Dexamethasone for the Treatment of Cervical Radiculopathy Phase II: RCT (placebo), Efficacy Study NCT00308594

Dexa-methasone; placebo

Cervical Radiculopathy

Term 100 Adt Nov-06 Nov-08 University of Manitoba



Chiropractic and Exercise Management of Spinal Dysfunction in Seniors Phase II/III: RCT (active) NCT01057706

Chiropractic; Behavioral: exercise

Neck Disability; Back Disability

Rec 300 Adt Sen

Jan-10 Aug-15 Northwestern Health Sciences University; Health Resources and Services Administration (HRSA)


Effectiveness of a general neck exercise program, of acupuncture or of repetitive low-energy shockwave therapy for chronic neck disorders RCT (active) ISRCTN99496264

General neck exercise program; acupuncture; low-energy shockwave thterapy

Neck disorders; Neck pain

Active 350 Adt Sen

Mar-10 Dec-12 German and International Society for Extracorporeal Shock Wave Therapy, Germay


The effect of various combinations of naprapathic manual therapy for patients with neck pain and/or back pain RCT (active) ISRCTN92249294

Naprapathic manual therapy; Naprapathic manual therapy excluding spinal manipulation; Naprapathic manual therapy except stretching

Non-specific back pain; Non-specific neck pain

Active 1050 Adt Mar-10 Dec-12 The Scandinavian College of Naprapathic Manual Medicine


Treatment of Chronic Thoracic and Neck and Upper Extremity Pain RCT (dose comparison), Safety/Efficacy Study NCT01071369

Thoracic and cervical interlaminar epidural injections; Drug: Xylocaine; Celestone

Back Pain; Neck Pain

Active, NR

240 Adt Sen

Feb-08 Feb-12 Pain Management Center of Paducah


Effectiveness of Manual Therapy in Patients With Neck Pain. RCT (active), Efficacy Study NCT00713843 & NTR1208

Manual Therapy Utrecht; Physical Therapy

Neck Pain Rec 180 Adt Sen

Sep-08 Dec-11 Radboud University; Stichting Garantiefonds Spaarneland, The Netherlands

http://ClinicalTrials.gov/show/NCT00713843 also http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1208











34

Comparing Two Different Cervical Collars for the Treatment in Patient With Cervical Radiculopathy and Radicular Pain RCT (active), Efficacy Study NCT00880828

FIR cervical collar + Acetaminophen; Conservative cervical collar + Acetaminophen; Drug: Acetaminophen only

Cervical Radiculopathy; Radicular Pain; Acute Neck Pain; Cervico-brachial Pain

Not yet Rec

72 Adt Sen

Aug-10 Oct-11 Taipei Medical University WanFang Hospital


Ultrasound Guided Diagnostic Cervical Medial Branch Block Single Group Assignment, Efficacy Study NCT00896688

Cervical medial branch blocks using the Quincke spinal needle

Facet Joint Disease; Neck Pain

Rec 25 Adt Jan-09 Jan-11 Hamilton Health Sciences





Active 12 Adt Nov-08 Nov-10 University Maastricht


Chiropractic for Back and Neck Pain in an Emergency Department Setting Phase I/II: RCT (placebo), Efficacy Study NCT00964717

Real Chiropractic; Sham Chiropractic

Back Pain; Neck Pain; Anxiety

Rec 90 Adt May-09

May-10

Assaf-Harofeh Medical Center


Electroacupuncture and Laser Therapy on Neck Pain Randomized, Parallel Assignment NCT00618878

Electro-acupuncture; Laser Therapy

Chronic Neck Pain

Rec 20 Adt Sen

Oct-08 Feb-10 Logan College of Chiropractic


Acupuncture for Back and Neck Pain in an Emergency Room Setting Phase I/II: RCT (placebo), Efficacy Study NCT00859365

Real Acupuncture; Placebo Acupuncture; No intervention

Back Pain; Neck Pain; Anxiety; Range of Motion

Rec 90 Adt Jan-09 Jan-10 Assaf-Harofeh Medical Center


The use of pulsed radiofrequency treatment into the atlantoaxial joint for the management of refractory head and neck pain. Single Group Assignment NTR2034

Pulsed radiofrequency into lateral atlantoaxial joint

Neck pain; Facialgie; Suboccipital pain; irradiating pain

N/K 100 Adt Sen

Jan-08 Jan-10 Orbis Medical Centrum











35

Cervical Epidural Pressure Measurement Randomized, Parallel Assignment NCT01009385

Cervical epidural steroid injection; Epidural pressure measurement

Head Pain; Neck Pain; Upper Extremity Pain

Invite 30 Adt Sen

Oct-09 Nov-09 Seoul National University Bundang Hospital


The Specificity of Cervical Facet Medial Branch Blocks RCT (dose comparison) NCT00613340

Cervical medial branch blocks

Neck Pain; Cervical Facet Arthropathy

Comp 20 Adt Sen

Jan-08 Apr-09 Johns Hopkins University; Army Regional Anesthesia and Pain Management Initiative


Relative Effectiveness and Adverse Effects of Cervical Manipulation, Mobilisation and the Activator Instrument in Patients With Sub-acute Non-specific Neck Pain: a Pragmatic Randomised Trial Randomized, Parallel Assignment, Safety/Efficacy Study NCT01029951

Manipulation; Mobilisation; Device: Activator instrument

Neck Pain Comp 47 Adt Jan-07 Mar-09 Anglo-European College of Chiropractic; European Chiropractors Union; National Institute for Chiropractic Research


Cross-Disciplinary Workplace Intervention Strategy for Chronic Musculoskeletal Disorders RCT (active), Efficacy Study NCT00369135

Combined intervention

Back Pain; Neck Pain; MSK Abnormalities

Rec 120 Adt Mar-06 Feb-09 Institut Universitaire Romand de Sante au Travail


Preventive Care of Chronic Cervical Pain and Disabilities RCT (active) NCT00566930

Spinal manipulation; Spinal manipulation + exercises

Neck Pain Rec 115 Adt Oct-07 Jan-09 Université du Québec à Trois-Rivière; Foundation for Chiropractic Education and Research (FCER)


Patients With Neck Pain Likely to Benefit From Thoracic Spine Thrust Mobilization Phase I: Randomized, Parallel Assignment NCT00504686

Manual therapy; Exercise

Neck Pain Comp 140 Adt Jan-07 Dec-08 Franklin Pierce University; Newton-Wellesley Hospital








36

The Effect of Chiropractic Manipulation on Spine-related Pain and Balance in Older Adults Single Group Assignment, Efficacy Study NCT00497718

Chiropractic Manipulation

MSK Equilibrium; Back Pain; Neck pain

Comp 75 Adt Sen

Feb-07 Dec-08 Cleveland Chiropractic College


Acupuncture for chronic neck pain: a pilot for a randomised controlled trial RCT ISRCTN06223266

Acupuncture + usual GP care; usual GP care

Chronic Neck pain

Comp 30 Adt Sen

May-05

Sep-08 University of York, UK


Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT RCT (placebo), Efficacy Study NCT00695006

Traction; Sham Traction

Cervical Radiculopathy

Active, NR

81 Adt Sen

Sep-06 Jul-08 Rocky Mountain University of Health Professions


Chiropractic and Exercise for Seniors With Neck Pain Phase II: RCT (active), Efficacy Study NCT00269308

Chiropractic Manual treatment + home exercise; Supervised rehabilitative exercise + home exercise; Home exercise

Neck Pain Active, NR

240 Adt Sen

Oct-03 Jul-08 Northwestern Health Sciences University; Health Resources and Services Administration (HRSA); Berman Center for Outcomes and Clinical Research


Diaphragmatic Movement Before and After Stellate Gaglion Block : A Ultrasonographic Study Phase IV NCT01054378

M-mode ultrasonography

Head Pain; Neck Pain; Shoulder Pain; Arm Pain; Neural Sensory Hearing Loss

Rec 60 Adt N/K ? Jan-10

Yonsei University http://ClinicalTrials.gov/show/NCT01054378


Association Between Neck Pain and Quality of Sleep Prospective NCT00907049

Chronic Neck Pain; Disability


Sep-09 Sep-11 Kovacs Foundation http://ClinicalTrials.gov/show/NCT00907049

Validation of a Novel Sham Cervical Spinal Manipulation Procedure NCT00978094

Chronic Neck Pain

Rec 80 Adt Feb-09 Jun-11 Canadian Memorial Chiropractic College










37

The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain Prospective, Cohort Study NCT00502333


Rec 1400 Adt Sen

Nov-06 Dec-10 Kovacs Foundation http://ClinicalTrials.gov/show/NCT00502333

Multi Cervical Unit Measures of Cervical Isometric Strength and Range of Motion: A Pilot Study Cohort Study NCT00510757

Cervicogenic Headache; Neck Pain; Whiplash; Kyphotic and Reversed Cervical Curves

Rec 200 Adt Jun-07 Jun-10 Logan College of Chiropractic


Unilateral Blindness/ Unilateral Deafness-Relation to Neck Pain Cross-sectional, Case Control NCT00589407

Neck Pain; Unilateral Blindness; Unilateral Deafness

Susp 300 ChildAdt

Oct-05 Oct-09 Hadassah Medical Organization


Cervicocephalic kinesthetic sensibility and postural balance in patients with non-traumatic chronic neck pain ISRCTN96873990

Mechanical non-traumatic chronic neck pain

Comp 30 Adt Oct-08 Nov-08 Scandinavian College of Chiropractic (Sweden)


The Natural History of Upper Trapezius Myofascial Trigger Points: Comparison of Local and Remote Tissue Milieu in Normal Muscle, Latent and Active Myofascial Trigger Points Over Time NCT00042276

Neck Pain Rec 100 Adt Jul-02 ? Apr-10

National Institutes of Health Clinical Center (CC)








38

A5: BACK PAIN


Interventions Conditions

Recruit n Age Grp

Start Date

End Date

Sponsors URL


Interactive Voice Response (IVR)-Based Treatment for Chronic Low Back Pain Randomized, Parallel Assignment, Efficacy Study NCT01025752

Face to face CBT; IVR based CBT

Chronic Low Back Pain

Not yet Rec

230 Adt Sen

Apr-10 Jan-14 Department of Veterans Affairs


Effect of Interventions in Return to Work for Patients With Neck and Low Back Pain RCT (active) NCT00840697

Exercises and work related rehabilitation

Low Back Pain Not yet Rec

600 Adt Aug-09 Apr-13 Ullevaal Uni. Hosp; The Research Council of Norway


An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers RCT (placebo), Efficacy Study NCT00782925

Educational program; Exercise program; Self-led exercises

Acute Low Back Pain

Rec 650 Adt Oct-08 Dec-12 Hospices Civils de Lyon


Effectiveness of tailored pain management in patients with chronic back pain RCT ISRCTN25592008

Graded activity exercise + individual CBT; strengthening + stretching exercises + group CBT

Chronic non-specific back pain

Active 120 Adt Sen

Jan-09 Dec-12 Zurzach Rehabilitation Foundation, SPA, Switzerland


Ibedrift - A Trial Comparing a New Approach to Musculoskeletal Pain Consisting of Education and Peer Involvement to Treatment as Usual Phase II/ III: Randomized, Parallel Assignment, Efficacy Study NCT00741650

Information and Peer advisor; Information, peer advisor and fast referral

MSK Pain; Low back pain

Active NR

5000 Adt Sen

Sep-08 Dec-12 UNIFOB A/S; RiksHospet HF








39

Spinal Cord Stimulator Implant Study RCT (placebo), Efficacy Study NCT00887419

Coping Skills Training; Education

Back Pain Rec 128 Adt Sen

Nov-08 Nov-12 Duke Uni.; Uni. of Michigan


Biopsychosocial Education and Chronic Low Back Pain Randomized, Parallel Assignment NCT00600197

Back school Chronic Low Back Pain

Active NR

170 Adt Sen

Jul-08 Sep-12 Tehran Uni. of Medical Sciences


Cognitive Interventions and Nutritional Supplementation for Patients With Long-lasting Back Pain Phase I: RCT (placebo), Efficacy Study NCT00463970

Brief Intervention; CBT; Dietary Supplement: Seal oil; Soy oil


Rec 600 Adt Feb-08 Aug-12 UNIFOB A/S; The Research Council of Norway; Uni. of Bergen; Haukeland Uni. Hosp


The Value of Traction in Treatment of Lumbar Radiculopathy Phase III RCT (active), Efficacy Study NCT00942227

Physical therapy rehabilitation

Sciatica; Radiculopathy; Spinal Diseases; MSK Diseases; Neuromuscular Diseases; Intervertebral Disk Displacement

Rec 120 Adt Jul-09 Jul-12 Intermountain Health Care, Inc.; Uni. of Utah; Wilford Hall Medical Center; Empi, A DJO Company


Rehabilitation of Patients With Modic Changes in the Lumbar Spine Randomized, Parallel Assignment NCT00454792

Exercise; Restitution

Low Back Pain Active NR

100 Adt Mar-07 Jun-12 The Back Research Center, Denmark


Improving Patient Choice in Treating Low Back Pain RCT (active) ISRCTN46035546

Physiotherapist trained on informed shared decision making; Physiotherapist not trained on informed shared decision making

Low back pain Active 150 Adt Sen

Apr-10 Mar-12 University of Warwick, UK


The COPE LBP trial: Cognitive Patient Education for Low Back Pain RCT (active) ISRCTN04323845

Cognitive intervention; usual care

Non-specific low back pain

Active 300 Adt Jan-09 Dec-11 Oslo University Hospital











40

Veterans Walk to Beat Back Pain RCT (active), Efficacy Study NCT00694018

Internet mediated enhanced pedometer intervention; Education and standard care


May-09

Sep-11 Department of Veterans Affairs


Work Related Rehabilitation in Patients With Low Back Pain Phase III: RCT (active), Efficacy Study NCT00526604

Work related rehabilitation

Low Back Pain Wtdwn 260 Adt Jan-08 Sep-11 Ullevaal Uni. Hosp http://ClinicalTrials.gov/show/NCT00526604

Treatment of Low Back Pain in Patients With End-stage Renal Disease on Hemodialysis Phase III: RCT (active), Efficacy Study NCT01095783

Physio-therapeutic intervention; Control


Rec 80 Adt Sen

Mar-09 Jul-11 Federal Uni. of Sao Paulo


Effectiveness of Group GDS and Individual GDS for Treatment of Low Back Pain in Primary Care RCT (active), Safety/Efficacy Study NCT01060280

Education on active management; Group GDS physiotherapy

Subacute Nonspecific Low Back Pain; Chronic Nonspecific Low Back Pain

Not yet Rec

462 Adt May-10

Jun-11 Kovacs Foundation http://ClinicalTrials.gov/show/NCT01060280

A Bio-psycho-social Exercise Program (RÜCKGEWINN) for Chronic Low Back Pain in Rehabilitation Aftercare Phase II/III RCT (active), Efficacy Study NCT01070849

Educational booklet;IRENA; RÜCKGEWINN

Low Back Pain Rec 456 Adt Nov-09 May-11

Uni. of Erlangen-Nürnberg Medical School; German Federal Pension Fund


Recurrent Low Back Pain:Linking Mechanisms to Outcomes Efficacy Study NCT01085604

Core Stabilization Low Back Pain, Mechanical

Rec 80 Adt Aug-09 May-11

Drexel Uni.; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)








41

Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain RCT (active), Efficacy Study NCT00108381

Tailored CBT; Standard care

Back Pain Active NR

162 Adt Sen

Jan-04 Apr-11 Department of Veterans Affairs


Evaluation of a risk tailored intervention among low back pain patients in primary care RCT (active) ISRCTN68205910

Risk tailored intervention; usual care


Active 1200 Adt Mar-09 Mar-11 German Federal ministry of Education and Research


The Effect of Two Short Education Programs for Nonspecific Low Back Pain in a Workers' Health Care Organization RCT (active), Efficacy Study NCT00665821

Classic back pain prevention education and CBT; General health education

Low Back Pain Term 657 Adt Sep-08 Feb-11 Kovacs Foundation; Hosp Laboral SOLIMAT


High(Deadlift) Versus Low Intensity Motor Control Exercises on Low Back Pain Phase II: RCT (active), Efficacy Study NCT01061632

High intensity motor control exercise (deadlift); Low intensity motor control exercise


70 Adt Jan-10 Jan-11 Luleå Tekniska Universitet


Qigong and Exercise Therapy for Low Back Pain in Adults RCT (active), Safety/Efficacy Study NCT00993980

Qigong; Exercise therapy


120 Adt Oct-09 Jan-11 Charite Uni., Berlin, Germany


Working Well With Back Pain (Feasibility RCT of Vocational Rehabilitation) Phase I/II: RCT (active), Efficacy Study NCT00817882

Individually targeted vocational rehabilitation; Routine back pain rehabilitation


50 Child Adt Sen

Mar-09 Dec-10 Uni. of Nottingham; Arthritis Research Campaign


Treatment for Nonspecific Low Back Pain in Primary Care: a Trial on Different Health Education Booklets Phase II: RCT (placebo), Efficacy Study NCT00361556

The Back Book; The Back Guide; General health book

Low Back Pain Rec 240 Adt Sen

Oct-05 Dec-10 Kovacs Foundation; Spanish Back Pain Research Network (REIDE)










42

Supervised Walking In comparison to Fitness Training for back pain RCT (active) ISRCTN17592092

Supervised walking; Fitness training

Chronic low back pain

Active 246 Adt Oct-08 Oct-10 Health Research Board, Ireland


The Step Back Up trial: the feasibility of a pedometer driven walking programme for chronic low back pain RCT (active) ISRCTN67030896

Walking; Education Chronic low back pain

Active 50 Adt Sep-09 Sep-10 University of Ulster, UK


Treatment of Veterans With Chronic Low Back Pain RCT (active), Efficacy Study NCT00361270

EMG Biofeedback without hypnotic suggestion; Home practice with hypnosis CDs; Therapist-guided hypnosis; Therapist-guided hypnosis + home practice with hypnosis CDs

Low Back Pain, Recurrent

Active NR

162 Adt Sen

Oct-06 Sep-10 Department of Veterans Affairs


Telehealth Outreach for Chronic Back Pain Phase I/ II: RCT (active), Efficacy Study NCT00608530

CBT; Rogerian psychotherapy

Pain; Back Pain Rec 130 Adt Sen

Mar-08 Sep-10 Department of Veterans Affairs; Uni. of California, San Diego


Managing Non-acute Low Back Symptoms in Occupational Health: Two Trials Phase III: Randomized, Factorial Assignment, Efficacy Study NCT00908102

Back book; Back book and Advice; Physical Medicine Unit; Documentation based care

Low Back Pain, Recurrent; Low Back Pain

Active NR

505 Adt Sep-01 Sep-10 Helsinki Uni.; Uni. of Oulu; Juho Vainio Foundation; Finnish Cultural Foundation; Yrjo Jahnsson Foundation


Effect of Yoga Vs. Stretching on Chronic Back Pain Phase II: RCT (active), Safety/Efficacy Study NCT00447668

Yoga; Exercise; Self-care book recommendations

Chronic Non-specific Low Back Pain

Active NR

210 Adt Mar-07 Aug-10 Group Health Cooperative; National Center for Complementary and Alternative Medicine










43



MSK Disorders: Neck, Shoulder and Back pain

Active NR



Specific Treatment Of Problems of the Spine (STOPS) Trials: Manual Therapy Group RCT (active) ACTRN12609000334202

Physiotherapy including manual therapy; Physiotherapy advice

Subacute low back pain with or without leg pain

N/K 150 Adt Jul-09 > Jul-10

La Trobe University http://www.anzctr.org.au/trial_view.aspx?ID=83864

Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE) RCT (active), Efficacy Study NCT00386243

CBT; Pain self-management program; Drug: Co-Analgesic Therapy; Opioid Analgesics

Low Back Pain; Pain; Pain, Intractable

Rec 300 Adt Sen

Dec-07 Jul-10 Department of Veterans Affairs


Specific Treatment Of Problems of the Spine (STOPS) Trials: Specific physiotherapy treatment and advice versus advice alone for sub-acute reducible discogenic low back pain: a randomised controlled trial. RCT (active) ACTRN12609000343202

Physiotherapy and physiotherapy advice; Physiotherapy advice alone

Reducible discogenic low back pain

N/K 124 Adt Jun-09 > Jun-10


Improving the effectiveness of primary care for low back pain: the Sub-grouping for Targeted Treatment (STarT Back) trial RCT ISRCTN37113406

Targeted physiotherapy program; usual care


Active 800 Adt Sen

Apr-07 Jun-10 Keele University, UK


Specific Treatment Of Problems of the Spine (STOPS) Trials: Effect of advice versus physiotherapy functional restoration on pain and function for people with multi-factorial persistent low back pain. RCT (active) ACTRN12609000293268

Physiotherapy functional restoration; Physiotherapy advice alone

Multi-factorial persistent low back pain

N/K 150 Adt May-09

> May-10


Early physiotherapy for acute low back pain RCT (active) ISRCTN19037867

Physiotherapy + usual care; usual care

Acute low back pain

Comp 50 Adt Oct-06 May-10

University of Southampton, UK














44

Illness perceptions and activity limitations in chronic low back pain. RCT ISRCTN35108886

Cognitive treatment; Waiting list control

Chronic non-specific low back pain

Comp 135 Adt Sen

Dec-04 May-10

Netherlands Organisation for Health Research & Development


Specific Treatment Of Problems of the Spine (STOPS) Trials: Effects of advice versus physiotherapy functional restoration on pain and function for people with lumbar disc herniation and associated radiculopathy RCT (active) ACTRN12609000205235

Physiotherapy functional restoration including advice; Physiotherapy advice

Lumbar disc herniation with associated radiculopathy

N/K 150 Adt Jul-09 > Jul-10


Pragmatic randomised controlled trial of yoga for the treatment of chronic low back pain RCT (active) ISRCTN81079604

Yoga; usual care Chronic Low back pain

Comp 262 Adt Apr-07 Mar-10 University of York, UK


Classification-Directed Treatment of Low Back Pain Phase I: Randomized, Parallel Assignment, Efficacy Study NCT00802724

Classification-directed treatment; Non-specific treatment

Low Back Pain Rec 100 Adt Jan-07 Mar-10 Eunice Kennedy Shriver National Institute of Child Health & Human Development; Washington Uni. School of Medicine


Physiotherapy for sleep disturbance in chronic low back pain trial RCT ISRCTN54009836

Supervised exercise class; usual physiotherapy; walking programme


Comp 60 Adt Sen

Oct-08 Feb-10 Health Research Board, Ireland


Prevention of Low Back Pain in the Military RCT (active), Safety/Efficacy Study NCT00373009

Traditional military training; Core stabilization military training; Psychosocial education military training; Combined military training


2700 Adt Feb-07 Feb-10 Uni. of Florida; Brooke Army Medical Center












45

Cost-effectiveness of exercise programmes to prevent low back pain and falls (I): low-frequency vibratory exercise RCT ISRCTN31946666

Low-frequency vibratory exercise; Usual care


Comp 60 Adt Sen

Sep-09 Jan-10 University of Extremadura, Spain


Specific Treatment of Problems of the Spine (STOPS) Trials: Effects of specific physiotherapy functional restoration and advice versus advice alone for people with sub-acute non-reducible discogenic low back pain. RCT (active) ACTRN12609000412235


Lumbar non-reducible discogenic pain

N/K 150 Adt Jun-09 > Dec-09


Specific Treatment Of Problems of the Spine (STOPS) Trials RCT (active) ACTRN12609000834257


Low back pain with or without sciatica

N/K 200 Adt Jun-09 > Dec-09

Health Networks Australia/ Lifecare Health; La Trobe University


Working Well with Back Pain - Phase 2 RCT (active) ISRCTN41520665

Group rehabilitation + targeted work-focused intervention; Group rehabilitation

Low back pain Comp 50 Adt Sen

May-09

Oct-09 University of Nottingham, UK


Exercise prescription for people with non-specific chronic low back pain RCT (active) ACTRN12608000524392

Exercise prescription informed by patient preference; Usual exercise prescription

Non-specific chronic low back pain

N/K 140 Adt Sen

Oct-08 > Oct-09

Monash University; National Health & Medical Research Council, Australia


Efficacy of Clinical Pilates versus general exercise for chronic low back pain: a randomised controlled trial. RCT (active), Efficacy study ACTRN12609000536268

Pilates; general exercise


N/K 86 Adt Sen

Jul-09 > Sep-09

University of Melbourne


Ultrasound Assessment During Exercise RCT (active), Efficacy Study NCT01015846

Exercise; Core stability exercise

Low Back Pain Comp 80 Adt Mar-09 Sep-09 Uni. of Virginia http://ClinicalTrials.gov/show/NCT01015846














46

Postural Re-education in Low Back Pain Phase I: Non-Randomized (active), Efficacy Study NCT00789204

Global Postural Re-education; Standard Exercise Training

Low Back Pain Comp 100 Adt Sen

May-08

Sep-09 Uni. of Bologna http://ClinicalTrials.gov/show/NCT00789204

Pilates and the effectiveness of the transversus abdominis in the individuals with low back pain Single Group Assignment ACTRN12609000927224

Pilates Low back pain Comp 20 Adt Jun-09 > Aug-09

Universidade do Estado de Santa Catarina


The effectiveness of Global Postural Reeducation Method (GPR) and conventional kinesiotherapy on pain, quality of life and functional disability in subjects with chronic spine pain. RCT (active) ACTRN12609000962235

Global Postural re-education; Kinesiology

Spine, Chronic pain; Chronic neck pain; chronic low back pain

Active NR

150 Adt Oct-07 > Aug-09

Universidade Federal de Sao Paulo


The role of attention re-training on pain tolerance in adults with acute low back pain RCT (placebo) ACTRN12608000380392

Attention retraining; placebo

Acute low back pain

N/K 128 Adt Sen

Jun-08 > Jun-09

University of Sydney


Interventional Study of Effects on Spine Height With Two Unloading Positions Single Group Assignment, Efficacy Study NCT01048749

Aquatic vertical suspension.; Land-based supine flexion


Aug-08 Jun-09 Texas Tech Uni. Health Sciences Center


Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain Phase II: RCT (placebo), Efficacy Study NCT00176163

Operant behavioral treatment; THC

Fibromyalgia; Back Pain

Comp 240 Adt Sen

Aug-05 May-09

Uni. of Heidelberg, Germany











47

Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction (MBSR) for Chronic Low Back Pain Phase II: RCT (active), Efficacy Study NCT00360802

CBT; Mindfulness Based Stress Reduction


Comp 330 Adt Sen

May-06

May-09

Kovacs Foundation; Spanish Back Pain Research Network; Fondo de Investigacion Sanitaria; Universitat Autonoma de Barcelona


Transmural occupational care for low back pain, a randomised controlled trial and cost-effectiveness evaluation RCT ISRCTN28478651

Graded activity protocol; workplace adaptations

Low back pain Comp 160 Adt Mar-05 Mar-09 TNO Quality of life (Work & Employment), The Netherlands


Participatory ergonomics for the primary prevention of back and neck pain: a cost-effectiveness study RCT (placebo) ISRCTN27472278

Participative ergonomic program

Back pain; Neck pain; prevention

Comp 3668 Adt Sen

Oct-07 Oct-08 VU University Medical Centre, The Netherlands


Anticipatory Muscle Control and Effect of Stabilizing Exercises in Patients With Subacute and Chronic Low Back Pain RCT (active), Efficacy Study NCT00201513

Exercise or information


99 Adt Jan-06 Oct-08 Norwegian Uni. of Science and Technology; Norwegian Fund for Postgraduate Training in Physiotherapy


UK-Back Skills Training Trial (UK-BeST) A multi-centred randomised controlled trial of a primary-care based cognitive behavioural program (CBP) for low back pain (LBP) RCT ISRCTN54717854

Group CBT Low back pain Comp 700 Adt Sen

Oct-03 Oct-08 Department of Health, UK


A Trial on the Effect on Low Back Pain Related Disability of Different Health Education Programs for Retired Persons Phase II: RCT (active), Efficacy Study NCT00441038

The Back Guide; The Back Book; Cardiovascular and general health

Low Back Pain Wtdwn 1100 Child Adt Sen

Dec-06 Sep-08 Kovacs Foundation; Conseill Insular de Ibiza y Formentera; Instituto de Asuntos Sociales y Deportes de Mallorca











48

Mindfulness Meditation for Chronic Low Back Pain in Older Adults RCT (active), Efficacy Study NCT00494845

Mindfulness (MBSR); Health Education Class


40 Adt Sen

Jul-07 Sep-08 Uni. of Pittsburgh; National Center for Research Resources (NCRR)


Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients Phase II: RCT (active), Efficacy Study NCT00439764

General health talk; Handout of The Back Book; Back exercise


Mar-07 Sep-08 Kovacs Foundation; Consejería de Sanidad, Junta de Castilla y León


Back School Efficacy on Low Back Pain and Quality of Life of Workers. COPCORD STUDY (Stage II) Phase III: Single Group Assignment, Efficacy Study NCT00596076

Back School Low Back Pain Comp 30 Adt Feb-08 Sep-08 Tehran Uni. of Medical Sciences


Tai chi for long-term low back pain RCT (active) ACTRN12608000270314

Tai Chi; Usual care Long-term low back pain

N/K 160 Adt Sen

Jun-08 > Aug-08

University of Sydney


BackReady coaching for return to usual activity RCT (active) ACTRN12607000458437

Motor control exercise; Graded activity


N/K 172 Adt Sen

Aug-08 > Aug-08

University of Sydney; University of Queensland


A pragmatic multicentre randomised controlled trial of yoga therapy for chronic low back pain RCT UKCRN ID 3915

Yoga Chronic low back pain

Active NR

262 Adt N/K Aug-08 University of York http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=3915

Could a Simple Information Booklet Modify Low Back Pain Patients Beliefs After Lumbar Discectomy? Phase III: RCT (active), Efficacy Study NCT00761111

Assessment of the Your Back Operation

Back Pain Active NR

140 Adt Sen

Jun-07 May-08

Uni. Hosp, Clermont-Ferrand


Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression RCT (active), Efficacy Study NCT00525811

Patient dialogue; Patient information

Acute Low Back Pain; Depression

Comp 741 Adt Jun-07 May-08

Uni. Hosp Freiburg http://ClinicalTrials.gov/show/NCT00525811








http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=3915




49

Device

Spinal Cord Stimulation With Precision® SCS System Versus Reoperation for Failed Back Surgery Syndrome Phase IV: Randomized, Parallel Assignment, Efficacy Study NCT01036529

Precision Spinal Cord Stimulation; Procedure: Back Surgery

Failed Back Surgery Syndrome; Leg Pain; Back Pain; Spinal Cord Stimulation

Rec 132 Adt Sen

Feb-10 Aug-15 Boston Scientific Corporation


Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain Randomized, Parallel Assignment NCT00924495

Transcranial magnetic stimulation

Chronic Nonspecific Low Back Pain

Rec 80 Adt

M-only

Jun-09 Dec-13 Kuopio Uni. Hosp http://ClinicalTrials.gov/show/NCT00924495

Efficacy Study of the Octapolar Lead in Patients With Failed Back Surgery Syndrome (FBSS) With Chronic Pain Phase IV: Single Group Assignment, Safety/Efficacy Study NCT01096147

Octad® lead (Spinal cord stimulation)

Failed Back Surgery Syndrome

Rec 300 Adt Sen

Feb-10 Aug-12 Medtronic Neuromodulation Europe


PSU Lumbar Support for Prevention of Low Back Pain in Rubber Tapper Phase III: RCT (active), Efficacy Study NCT01017588

PSU lumbar back support


200 Child Adt

Jan-10 Jun-12 Prince of Songkla Uni.


Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System RCT (placebo), Efficacy Study NCT00802997

Sinergy; Placebo/Sham

Sacroiliac Pain Rec 51 Adt Sen

Jun-08 Dec-11 Coastal Orthopedics & Sports Medicine


Study of the Safety and Effectiveness of DIAM™ Spinal Stabilization System vs. Conservative Care Phase III: RCT (active), Safety/Efficacy Study NCT00456378

DIAM™ Spinal Stabilization System; Conservative care

Lumbar Degenerative Disc Disease

Rec 306 Adt Sen

Dec-06 Nov-10 Medtronic Spinal and Biologics








50

Trial on the Effect of Optically Modified Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain RCT (placebo), Safety/Efficacy Study NCT00969540

Specific mattress cover; Placebo garment mattress cover

Back Pain; Insomnia

Active NR

6 Adt Sen

Jun-09 Jun-10 Uni. of California, Irvine


A study to investigate the effect of a new postural bio-feedback device on low back pain. RCT (placebo) ACTRN12609000157279

Postural bio-feedback device; Postural device with bio-feedback disabled

Low back pain Active 48 Adt May-09

> May-10

Pro-Active Medical, Melbourne


The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain Randomized, Parallel Assignment, Safety/Efficacy Study NCT00925951

Wet Cupping; Drug: Acetaminophen

Low Back Pain Comp 37 Adt Jun-09 Dec-09 Korea Institute of Oriental Medicine


Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Pain, Responders and Non-Responders? Observational: Prospective, Cohort Study NCT00885859

TENStemeco Schwa Medico (TENS)


Not yet Rec

62 Adt Sen

Jun-09 Dec-09 Maastricht Uni. Medical Center


Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study Factorial Assignment NCT00706459

Magnetic Resonance Imaging

Degenerative Disc Disease

Rec 105 Adt Mar-05 Dec-09 Uni. of California, San Francisco; National Institutes of Health (NIH)


Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression System for Treatment of Low Back Pain Phase II: RCT (active), Safety/Efficacy Study NCT00469118

DRX9000™ Low Back Pain Term 6 Adt Sen

Feb-09 Nov-09 NEMA Research, Inc.


Orthotic Use for Chronic Low Back Pain NCT00976664

Shoe orthotic Chronic Low Back Pain

Rec N/K Adt Sen

N/K ? Sep-09

National Uni. of Health Sciences; Foot Levelers, Inc.










51

A Randomized Prospective Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain Randomized, Parallel Assignment, Efficacy Study NCT00553540

Back supports Low Back Pain Active NR

50 Adt Oct-06 Aug-09 Cleveland Clinic Florida; Integral Orthopedics Inc.


Effectiveness of Mechanical Decompression for Low Back Pain Relief RCT (placebo) NCT00704210

SpineMed Table, Cert HealthSciences LLC


128 Adt Sen

Aug-06 Jul-09 State Uni. of New York - Upstate Medical Uni.


The Effectiveness of the Logic Back™Support. Non-Randomized, Parallel Assignment (placebo) NCT00754585

Logic Back Grahl Duo Back Model

DB11‐01

Low Back Pain; Posture

Rec 24 Adt

M-only

Aug-08 May-09

Canadian Memorial Chiropractic College; Logic Back; McMaster Uni.


Non-Invasive Targeted Electronic Pain Control Device (“Biowave System”) versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain Phase III: RCT (active), Safety/Efficacy Study NCT00277797

Biowave Targeted Non-Invasive Electronic Pain Control Device; TENS device


Active NR

50 Adt Feb-01 Apr-09 Weill Medical College of Cornell Uni.; Biowave Corporation


Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity Phase IV: RCT (active), Efficacy Study NCT00399841

Precision for Spinal Cord Stimulation

Intractable Neuropathic Pain; Pain; Back Pain; Lower Extremity Pain

Term 13 Adt Sen

Nov-06 Feb-09 Boston Scientific Corporation


E-STIM Trial: Comparing the Efficacy of the Empi Select TENS to a Control for the Treatment of Chronic Lower Back Pain RCT (placebo), Efficacy Study NCT00709748

Empi Select TENS Device; Placebo

Lower Back Pain Rec 300 Adt Feb-08 Feb-09 Empi, A DJO Company; Alquest








52

Electrical Acupuncture and Laser Therapy for Low Back Pain Phase I/ II: Randomized, Parallel Assignment, Efficacy Study NCT00779818

Electrical acupuncture; Laser


Rec 40 Adt Oct-08 Jan-09 Logan College of Chiropractic


Restoration of Disc Height Reduces Chronic Low Back Pain Observational: Retrospective, Cohort Study NCT00828880

DRX9000; non invasive spinal decompression


Comp Adt Sen

N/K ? Jan-09

NEMA Research, Inc.; Axiom Worldwide, LLC


Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients Phase IV: RCT (placebo), Efficacy Study NCT00290238

Vertis Percutaneous Neuromodulation Therapy (PNT); Transcutaneous Electrical Nerve Stimulation (TENS)

Low Back Pain Term 122 Adt Sen

Dec-05 Sep-08 RS Medical http://ClinicalTrials.gov/show/NCT00290238

Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-Radiculalgia Phase IV: RCT (placebo), Efficacy Study NCT00452010

CEFAR PRIMO TENS Class IIA (active); CEFAR PRIMO TENS Class IIA (no active)

Chronic Low Back Pain; Chronic Lumbo-Radiculalgia

Comp 236 Adt Sen

Sep-06 Sep-08 Centre Hospier Universitaire de Saint Etienne; Ministry of Health, France


Prometra's Utilization in Mitigating Pain II NCT00866164

Prometra Programmable Pump

Intractable Pain; Back Pain; Leg Pain; Arm Pain; Trunk Pain

Expand N/K Adt Sen

InSet Technologies http://ClinicalTrials.gov/show/NCT00866164


Efficacy of Antidepressants in Chronic Back Pain Phase II: Randomized, Parallel Assignment, Efficacy Study NCT00964886

Desipramine hydrochloride; Desipramine hydrochloride + CBT; CBT; Benztropine mesylate + CBT; Placebo

Back Pain Not yet Rec

200 Adt Sen

Jan-10 Dec-14 Department of Veterans Affairs; Uni. of California, San Diego








53

The Effectiveness of Selective Nerve Root Injections in Preventing the Need for Surgery Phase III: RCT (placebo), Efficacy Study NCT01073995

Kenalog; Sensorcaine

Radiculopathy Rec 100 Adt Mar-10 Mar-14 Saint John Regional Hosp


Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis RCT (active), Safety/Efficacy Study NCT01052571

Lumbar transforaminal epidural injections


120 Adt Sen

Feb-10 Jan-14 Pain Management Center of Paducah


Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients RCT (active), Safety/Efficacy Study NCT01053572

Celestone; Substitute Celestone; Substitute Hypertonic Sodium Chloride; Substitute hypertonic sodium chloride and Celestone

Low Back Pain Invite 240 Adt Sen



A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Low Back Pain Phase II: Parallel Assignment, Safety/Efficacy Study NCT00973024

JNJ-42160443; Placebo

Low Back Pain; Low Back Pain, Recurrent

Active NR

360 Adt Sen

N/K Dec-12 Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System Phase III: RCT (placebo), Safety/Efficacy Study NCT01011816

Biostat System; Sodium Chloride Injection

Back Pain; Chronic Low Back Pain; Internal Disc Disruption; Degenerative Disc Disease

Rec 260 Adt Sen

Mar-10 Aug-12 Spinal Restoration, Inc.


Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis Phase IV: RCT (dose comparison), Safety/Efficacy Study NCT00715091

Diclophenac Ankylosing Spondylitis

Not yet Rec

360 Adt Jul-08 Jul-12 Charite Uni., Berlin, Germany








54

Intra-Discal Steroid Injection for MODIC I Discopathy Phase IV: RCT (placebo), Safety/Efficacy Study NCT00804531

Visipaque - Hydrocortancyl; Placebo


Active NR

134 Adt Oct-08 Jan-12 Assistance Publique - HÃ´pitaux de Paris


A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis Phase III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00265083

Golimumab; Placebo

Spondylitis, Ankylosing

Active NR

356 Adt Sen

Nov-05 Jan-12 Centocor, Inc.; Schering-Plough


The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM) Phase IV: RCT (active), Safety/Efficacy Study NCT00713258

Parathyroid hormone (PTH) (1-84); Alendronate

Back Pain Active NR

300 Adt Sen

F-

only

Apr-08 Dec-11 Nycomed http://ClinicalTrials.gov/show/NCT00713258

Long Term Safety Study of Tanezumab in Chronic Low Back Pain Phase II/III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00924664

Tanezumab 20 mg; Tanezumab 10 mg


Aug-09 Nov-11 Pfizer http://ClinicalTrials.gov/show/NCT00924664

Pilot Study to Assess the Efficacy of Botulinum Toxin A Treatments on Pain and Disability in Sub-Acute Low Back Pain Phase IV: RCT (placebo), Efficacy Study NCT00384371

Botulinum Toxin A; Placebo

Low Back Pain Term 0 Adt Jun-08 Sep-11 Department of Defense


Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain Phase III: RCT (active), Safety/Efficacy Study NCT01081912

Hydrocodone bitartrate; Placebo


Rec 340 Adt Sen

Mar-10 Jun-11 Zogenix, Inc. http://ClinicalTrials.gov/show/NCT01081912







55

Treatment of Notalgia Paresthetica With Xeomin Phase III: Randomized, Crossover Assignment, Safety/Efficacy Study NCT01098019

Xeomin; Placebo Notalgia Paresthetica

Rec 20 Adt Sen

Apr-10 May-11

Innovaderm Research Inc.; Merz Pharmaceuticals GmbH


Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica Phase II: RCT (placebo), Efficacy Study NCT00668434

Prednisone; Placebo

Sciatica Rec 270 Adt Nov-08 May-11

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Analgesic Efficacy of Intravenous Lidocaine for Postoperative Pain Following Adult Spine Surgery RCT (dose comparison), Efficacy Study NCT01043211

Lidocaine Hydrochoride Injection, without epinephrine; Normal Saline


100 Adt Sen

Apr-10 Apr-11 Uni. of Alabama at Birmingham


Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Subjects Phase I: Randomized, Parallel Assignment, Pharmacokinetics Study NCT00961766

BG00010; Placebo Sciatica Rec 56 Adt Sen

Aug-09 Apr-11 Biogen Idec http://ClinicalTrials.gov/show/NCT00961766

Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug (NSAID) Treatment Phase III: Single Group Assignment, Safety Study NCT00984815

HZT-501 OA; RA; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain

Rec 100 Adt Sen

Sep-09 Mar-11 Horizon Therapeutics, Inc.


A Study for Teriparatide in Severe Osteoporosis Observational: Prospective, Cohort Study NCT00696644

Teriparatide Osteoporosis, Post-menopausal; Osteoporosis

Active NR

650 Adt Sen

Jun-08 Feb-11 Eli Lilly and Company








56

Study of FORTEO Use in Subjects in the Community Setting Observational: Prospective, Cohort Study NCT01078805

FORTEO Osteoporosis Active NR

4126 Child Adt Sen

Aug-03 Feb-11 Eli Lilly and Company


Efficacy and Safety of EN3324 in Subjects With Chronic Low Back Pain Phase II: Randomized, Parallel Assignment, Efficacy Study NCT01043263

EN3324; Placebo Chronic Low Back Pain

Rec 240 Adt Sen

Dec-09 Feb-11 Endo Pharmaceuticals


Botulinum Toxin A for the Treatment of Chronic Lumbar Back Pain Phase IV: RCT (placebo), Efficacy Study NCT00404417

Botulinum Toxin A; Placebo


Active NR

160 Adt Sen

Mar-07 Feb-11 Walter Reed Army Medical Center


Vitamin D Treatment to Patients Suffering From Chronic Pain and Vitamin D Hypovitaminosis RCT (placebo), Safety/Efficacy Study NCT01023490

Vitamin D; Placebo Back Pain; Hypo-vitaminosis D

Not yet Rec

40 Adt Sen

Jan-10 Jan-11 Tel-Aviv Sourasky Medical Center


Back Pain in Patients With Severe Osteoporosis Observational: Prospective, Cohort Study NCT00761332

Teriparatide; Antiresorptives

Osteoporosis Active NR

600 Adt Sen

Feb-08 Jan-11 Eli Lilly and Company


Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain Phase II: Randomized, Parallel Assignment, Efficacy Study NCT01001715

REGN475/SAR164877; Placebo


Nov-09 Jan-11 Sanofi-Aventis; Regeneron Pharmaceuticals


Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain Phase II: RCT (placebo), Efficacy Study NCT01096966

Bupivacaine TTS (Bupivacaine Patch); Placebo


Rec 260 Adt Sen

Mar-10 Jan-11 King Pharmaceuticals Research and Development; Durect Corporation









57

Lumbar Stenosis Outcomes Research II Phase IV: Randomized, Crossover Assignment NCT00652093

Propoxyphene/ acetaminophen; Oxymorphone hydrochloride; Placebo

Neurogenic Intermittent Claudication

Rec 48 Adt Sen

Mar-08 Dec-10 Uni. of Rochester; Endo Pharmaceuticals


Combination Disease-Modifying Antirheumatic Drugs (DMARDs) Versus Sulfasalazine in Inflammatory Back Pain Phase III: RCT (placebo), Efficacy Study NCT01040195

Methotrexate, Hydroxy-chloroquine; Placebo

Seronegative Spondylo-arthropathies

Rec 100 Adt Jun-09 Dec-10 Sanjay Gandhi Postgraduate Institute of Medical Sciences


A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy Phase II/ III: RCT (placebo), Efficacy Study NCT00733096

Etanercept; Methyl-prednisolone; Normal saline

Lumbosacral Radiculopathy

Rec 78 Adt Sen

Aug-08 Dec-10 Johns Hopkins Uni.; Walter Reed Army Medical Center; National Naval Medical Center; Womack Army Medical Center; Landstuhl Regional Medical Center; Massachusetts General Hosp


A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis Phase IV: RCT (active), Safety/Efficacy Study NCT00784810

Oxycodone/ Naloxone

OA; Back Pain Active NR

244 Adt Sen

Jan-09 Nov-10 Napp Pharmaceuticals Limited


Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain Phase IV: RCT (placebo), Efficacy Study NCT00227292

Escitalopram; Placebo

Low Back Pain; Depression

Rec 106 Adt Nov-07 Nov-10 Martin-Luther-UniversitÃ¤t Halle-Wittenberg







58

Efficacy of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis Phase I/II: RCT (active), Efficacy Study NCT00809159

AIN457; Placebo Ankylosing Spondylitis

Rec 30 Adt Mar-09 Nov-10 Novartis http://ClinicalTrials.gov/show/NCT00809159

NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain Phase III: Randomized, Parallel Assignment, Efficacy Study NCT00986180

NUCYNTA; Oxycodone IR

Pain; Back Pain; Low Back Pain; Back Pain With Radiation

Rec 652 Adt Sen

Sep-09 Oct-10 Ortho-McNeil Janssen Scientific Affairs, LLC; GrÜnenthal


Epidural Study of Patients With Chronic Lower Back Pain RCT (dose comparison), Efficacy Study NCT00887003

Bupivacaine; Depo-Medrol


Rec 280 Adt Sen

May-05

Sep-10 Hamilton Health Sciences


Double-blind, randomised, placebo-controlled prospective multicenter phase III trial to assess the efficacy and safety of topical propyl nicotinate (Elacur® hot) in adjuvant treatment of chronic non-specific low back pain Phase III: RCT (placebo) DRKS00000183

Propyl nicotinate cream; Placebo cream


N/K 460 Adt Sen

Aug-10 > Aug-10

Riemser Arzneimittel AG, Germany

http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000183

Pilot Study to Assess the Efficacy of Botulinum Toxin B on Pain and Disability in Subjects With Acute Low Back Pain Phase IV: RCT (placebo), Efficacy Study NCT00384579

Botulinum toxin B; Placebo

Low Back Pain Term 0 Adt Feb-08 Aug-10 Department of Defense


SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation Phase II/III: RCT (placebo), Safety/Efficacy Study NCT00634946

SI-6603; Placebo Lumbar Vertebra Hernia

Active, not Rec

195 Adt Sen

Jan-08 Aug-10 Seikagaku Corporation










59

Efficacy of Pregabalin in Patients With Radicular Pain Phase IV: RCT (placebo), Efficacy Study NCT00908375

Pregabalin; Sugar Pill

Lumbar Radicular Pain; Failed Back Surgery Syndrome; Spinal Stenosis; Herniated Disc

Rec 38 Adt May-09

Jul-10 Northwestern Uni. http://ClinicalTrials.gov/show/NCT00908375

Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy Randomized, Parallel Assignment NCT00619983

Donepezil; Duloxetine; Donepezil & Duloxetine; Gabapentin; Placebo

Diabetic Neuropathic Pain; Chronic Low Back Pain

Rec 60 Adt Sen

Feb-08 Jul-10 Wake Forest Uni.; National Institute of Neurological Disorders and Stroke (NINDS)


A Study of Tanezumab in Adults With Chronic Low Back Pain Phase II: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00876187

Tanezumab 20mg, 10mg & 5mg IV; Naproxen; Placebos


Jun-09 Jul-10 Pfizer http://ClinicalTrials.gov/show/NCT00876187

Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability Phase III: Single Group Assignment, Safety/Efficacy Study NCT00986258

Tapentadol Chronic Pain Due to Low Back Pain

Rec 180 Adt Sen

Sep-09 Jun-10 GrÜnenthal GmbH http://ClinicalTrials.gov/show/NCT00986258

Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase III: Single Group Assignment, Safety/Efficacy Study NCT00983385

Tapentadol Chronic Pain; Low Back Pain

Rec 180 Adt Sen

Sep-09 Jun-10 GrÜnenthal GmbH http://ClinicalTrials.gov/show/NCT00983385






60

Efficacy and Safety of Ralfinamide in Patients With Chronic Neuropathic Low Back Pain Phase III: RCT (placebo), Safety/Efficacy Study NCT01019824

Ralfinamide Pain Active NR

400 Adt Sen

Jan-09 Jun-10 Newron Pharmaceuticals S.p.A.; Parexel; CliniRx


A Pilot Trial of Intravenous (IV) Pamidronate for Low Back Pain Phase I: Single Group Assignment, Randomized Study NCT00101790

Pamidronate Low Back Pain Active NR

44 Adt Sen

Sep-03 Jun-10 Mount Sinai School of Medicine; National Institute of Neurological Disorders and Stroke (NINDS)


Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication Randomized, Crossover Assignment NCT00388414

Duloxetine Low Back Pain Active NR

75 Adt Sep-06 Jun-10 Stanford Uni. http://ClinicalTrials.gov/show/NCT00388414

A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain Phase II: RCT (placebo), Safety/Efficacy Study NCT00991172

REGN475; REGN475; Placebo Injection

Sciatica Active NR

150 Adt Nov-09 May-10

Regeneron Pharmaceuticals; Sanofi-Aventis


Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected Phase I: Non-Randomized, Parallel Assignment, Efficacy Study NCT01030640

Tanezumab; Placebo

OA Pain; Chronic Low Back Pain; Pain Due to Interstitial Cystitis

Active NR

28 Adt Jan-10 Apr-10 Pfizer http://ClinicalTrials.gov/show/NCT01030640

Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults Phase IV: RCT (active), Efficacy Study NCT00696293

Duloxetine + Clinical Management; Duloxetine + Problem Solving Therapy for Depression and Pain (PST-DP).

Major Depressive Disorder; Back Pain; Aged

Comp 80 Adt Sen

May-07

Apr-10 Uni. of Pittsburgh; National Institutes of Health (NIH); Eli Lilly and Company








61

Study to Assess the Effectiveness and Safety of FLECTOR® Patch for Treatment of Acute Back Strain Phase IV: Single Group Assignment, Efficacy Study NCT01054820

FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%

Acute Back Strain

Comp 123 Adt Sen

Jan-10 Mar-10 Alpharma Pharmaceuticals LLC, a subsidiary of King Pharmaceuticals, Inc.


Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain RCT (dose comparison), Safety/Efficacy Study NCT00370799

Caudal epidural injection; Caudal Epidural Injection with generic Celestone; Caudal Epidural Injection with Celestone; Caudal Epidural Injection with DepoMedrol


240 Adt Sen

Jan-06 Mar-10 Pain Management Center of Paducah


Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion RCT (placebo) NCT00644111

Bupivicaine, Hydromorphone; Saline Placebo


Feb-08 Mar-10 Uni. Health Network, Toronto


Paracetamol for low back pain RCT (placebo), Efficacy Study ACTRN12609000966291

Paracetamol, time contingent; PRN Paracetamol; Placebo

Low back pain N/K 1650 Child Adt Sen

Nov-09 > Feb-10

The George Institute of International Health


A Confirmatory Study of JNS020QD (Fentanyl) in Patients With Osteoarthritis or Low Back Pain Phase III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT01008618

Fentanyl; JNS020 Pain Comp 151 Adt Sen

Sep-08 Feb-10 Janssen Pharmaceutical K.K.








62

Double-blind, randomised, multi-centre, placebo-controlled clinical trial to investigate the efficacy and safety of a combination of comfrey root extract plus methyl nicotinate versus a preparation containing methyl nicotinate alone or placebo in patients with conditions of acute upper or low back pain Phase III: RCT (placebo) DRKS00000326

Comfrey root extract + methyl nicotinate; methyl nicotinate

Low back pain; pain in thoracic spine

N/K 390 Adt Nov-09 > Jan-10

Merck Selbst-medikation GmbH


Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis Phase III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00771758

Oxycodone IR; Tapentadol IR; placebo

Back Pain Comp 108 Adt Sen

Aug-08 Dec-09 Ortho-McNeil Janssen Scientific Affairs, LLC; GrÜnenthal GmbH


D-cycloserine in the Management of Chronic Low Back Pain Phase II: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00125528

D-cycloserine; placebo

Low Back Pain; Pain

Not yet Rec

39 Adt Sen

N/K ? Dec-09

Northwestern Uni.; Rehabilitation Institute of Chicago


Efficacy and Safety of Extended Release Tramadol HCl/Acetaminophen for the Treatment of Chronic Low-back Pain Phase III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT01112267

Tramadol HCl/ acetaminophen Extended Release; Placebo


May-09

Oct-09 Janssen Korea, Ltd., Korea


Phase 3 Clinical Trial of Teriparatide in Japan Phase III: RCT (placebo), Safety/Efficacy Study NCT00433160

Teriparatide; Placebo

Osteoporosis Comp 207 Adt Sen

Jan-07 Sep-09 Eli Lilly and Company


Chronic Low Back Pain Research Project Phase II: RCT (placebo), Efficacy Study NCT00108550

Gabapentin; Placebo


Comp 115 Adt Sen











63

Study of the Insomnia in Patients With Low Back Pain Phase IV: RCT (placebo), Efficacy Study NCT00365976

Eszopiclone; Placebo

Primary Insomnia

Rec 140 Adt Aug-06 Sep-09 Duke Uni.; Sepracor, Inc.


Antibiotic Treatment to Patients With Low Back Pain Phase IV: RCT (placebo), Efficacy Study NCT00302796

Bioclavid Back Pain Rec 162 Adt Mar-06 Sep-09 The Back Research Center, Denmark


Treatment With ARRY-371797 in Patients With Active Ankylosing Spondylitis Phase II: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00811499

ARRY-371797; Placebo

Ankylosing Spondylitis

Comp 25 Adt Sen

Dec-08 Sep-09 Array BioPharma http://ClinicalTrials.gov/show/NCT00811499

Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip, Knee and/or Lumbar Spine Phase IV: RCT (active), Safety/Efficacy Study NCT00426647

Buprenorphine; Tramadol

OA; Pain, Lumbar spine, hip or knee

Comp 120 Adt Sen

Feb-07 Aug-09 Norpharma A/S; Mundipharma Finland


Opiate-Induced Tolerance & Hyperalgesia in Pain Patients Phase IV: Randomized, Parallel Assignment NCT00246532

Morphine; Placebo Chronic Low Back Pain; Opioid-induced Hyperalgesia

Comp 160 Adt Sen

Oct-05 Aug-09 National Institute of General Medical Sciences (NIGMS)


The Glucosamine-Study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain Phase IV: RCT (placebo), Efficacy Study NCT00404079

Glucosamine sulphate; Placebo


250 Adt Sen

Dec-06 Aug-09 Ullevaal Uni. Hosp; Stiftelsen Helse og Rehabilitering


Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis Phase IV: RCT (placebo), Safety/Efficacy Study NCT00647517

Ultracet Ankylosing Spondylitis

Comp 60 Adt Mar-08 Jul-09 Chung Shan Medical Uni.









64

A Study for Patient With Chronic Low Back Pain Phase III: RCT (placebo), Safety/Efficacy Study NCT00767806

Duloxetine; Placebo Chronic Low Back Pain

Comp 395 Adt Sen

Sep-08 Jul-09 Eli Lilly and Company


A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms Phase II: Randomized, Parallel Assignment NCT00817986

Arbaclofen Placarbil Back Spasms Comp 161 Adt Dec-08 Jul-09 XenoPort, Inc. http://ClinicalTrials.gov/show/NCT00817986

Efficacy Safety of a Combination Thiocolchicoside+Ketoprofen Compared to Thiocolchicoside Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain Phase III: RCT (active), Safety/Efficacy Study NCT00679146

Thiocolchicoside+ Ketoprofen; Thiocolchicoside

Low Back Pain Comp 322 Adt Apr-08 Jun-09 Sanofi-Aventis http://ClinicalTrials.gov/show/NCT00679146

An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain Phase III: Single Group Assignment, Safety/Efficacy Study NCT00487435

CG5503 Pain; OA; Low Back Pain

Comp 1166 Adt Sen

Feb-07 Jun-09 Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Grünenthal GmbH


Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP). Phase III: Randomized, Parallel Assignment NCT00763321

ABT-712; Placebo Chronic Low Back Pain

Comp 223 Adt Sen

Aug-08 Apr-09 Abbott http://ClinicalTrials.gov/show/NCT00763321






65

Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back Phase III: RCT (placebo), Safety/Efficacy Study NCT00671879

Carisoprodol SR 700 mg; Carisoprodol SR 500 mg; Placebo

Lower Back Pain Comp 840 Adt Sen

Apr-08 Mar-09 Meda Pharmaceuticals


Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP). Phase III: Randomized, Parallel Assignment NCT00761150

ABT-712; Placebo Chronic Low Back Pain

Comp 200 Adt Sen

Aug-08 Mar-09 Abbott http://ClinicalTrials.gov/show/NCT00761150

A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Acetaminophen and Tramadol Combination BID Versus Placebo for the Treatment of Acute Low Back Pain Phase III: Parallel Assignment NCT00643383

Combination drug (Acetaminophen + Tramadol); Placebo

Acute Low Back Pain

Comp 250 Adt Sen

Mar-08 Feb-09 Labopharm Inc. http://ClinicalTrials.gov/show/NCT00643383

Epidural Clonidine for Lumbosacral Radiculopathy RCT (active), Efficacy Study NCT00588354

Clonidine; Triamcinolone

Acute Lumbosacral Radiculopathy Due to Herniated Disk

Active NR

40 Adt Sen

Oct-06 Feb-09 Mayo Clinic http://ClinicalTrials.gov/show/NCT00588354

A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back Phase III: RCT (active), Safety/Efficacy Study NCT00671502

Carisoprodol; Carisoprodol SR; Placebo

Lower Back Pain Comp 840 Adt Sen

Apr-08 Feb-09 Meda Pharmaceuticals







66

Study to Test the Effectiveness of Controlled-Release OROS® Hydromorphone HCl Compared to Placebo in Patients With Chronic Low Back Pain Phase III: RCT (placebo), Efficacy Study NCT00549042

OROS® hydromorphone at 4, 8, 16, and 32 mg tablets used to provide doses of 12-64mg.


Comp 450 Adt Sen

Sep-07 Jan-09 Neuromed Pharmaceuticals


Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain Phase III: RCT (placebo), Efficacy Study NCT00567736

Disci/Rhus toxicodendron comp.®; placebo solution


Comp 150 Adt Sen

Aug-07 Jan-09 Charite Uni., Berlin, Germany; WALA Heilmittel GmbH


Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940 Phase I: Randomized, Parallel Assignment, Safety Study NCT00689780

AZD1940; Midazolam

Low Back Pain Comp 60 Adt Mar-08 Jan-09 AstraZeneca http://ClinicalTrials.gov/show/NCT00689780

Neuraxial Pethidine After Lumbar Surgery Trial Phase III: RCT (placebo), Safety/Efficacy Study NCT00163553

Pethidine; Placebo Sciatica Rec 60 Adt Sen

Dec-04 ? Jan-09

Austin Health http://ClinicalTrials.gov/show/NCT00163553

Study on Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain Observational: Prospective, Cohort Study NCT00797017

Fentanyl Low Back Pain Comp 1576 Adt Sen

May-08

Dec-08 Janssen Korea, Ltd., Korea


A Study to Evaluate the Effectiveness and Safety of CG5503 Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain Phase III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00449176

CG5503; Oxycodone; placebo


Feb-07 Dec-08 Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Grünenthal GmbH








67

Epidural Sacral Injection study: effect of volume and triamcinolone on chronic lumbosacral radiculopathy? RCT (placebo) ISRCTN12574253

Triamcinolone; Saline

Sciatica; Lumbosacral radiculopathy

Comp 240 Adt May-05

Dec-08 University Hospital of North Norway


Lumbar Spinal Fibrosis and TNF Alpha Inhibition Phase III: RCT (placebo), Efficacy Study NCT00385086

TNF blocker Post Operative Sciatica by Lumbar Spinal Fibrosis

Rec 40 Adt Sen

Feb-07 Nov-08 Assistance Publique - Hopitaux de Paris


Double-Blind Follow-on Safety Study of HZT-501 in Subjects Who Have Completed Participation in HZ-CA-301 or HZ-CA-303 Phase III: RCT (active), Safety Study NCT00613106

Ibuprofen/ famotidine; Ibuprofen

OA; RA; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain

Comp 300 Adt Sen

Sep-07 Oct-08 Horizon Therapeutics, Inc.


Duloxetine Versus Placebo in Chronic Low Back Pain Phase III: RCT (placebo), Safety/Efficacy Study NCT00424593

Duloxetine; Placebo Back Pain Without Radiation

Comp 236 Adt Sen

Jan-07 Oct-08 Eli Lilly and Company


Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain Phase III: RCT (placebo), Efficacy Study NCT00490919

Buprenorphine transdermal delivery systems; Placebo


Jun-07 Oct-08 Purdue Pharma LP http://ClinicalTrials.gov/show/NCT00490919

A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain Phase III: Randomized, Parallel Assignment, Efficacy Study NCT00662558

Celecoxib; Tramadol HCL


Jan-08 Sep-08 Pfizer http://ClinicalTrials.gov/show/NCT00662558

RN624 In Adult Patients With Chronic Low Back Pain Phase II: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00584870

PF-04383119 (RN624); Naproxen; Placebo


Jul-07 Sep-08 Pfizer http://ClinicalTrials.gov/show/NCT00584870









68

Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain - A Double Blind, Randomised, Placebo Controlled Clinical Trial Phase III: RCT (placebo), Efficacy Study NCT00327730

Eperisone Muscle Spasm; Back Pain

Comp 240 Adt Oct-06 ? Sep-08

Eisai Inc.; Eisai Limited


SLURP: Steroid injections in LUmbosacral Radicular Syndrome RCT (active) ISRCTN54386944

Epidural corticosteroid injection (80mg Kenacort); usual care

Lumbosacral Radicular Syndrome

Comp 80 Adt Sep-05 Sep-08 University Medical Centre Groningen, The Netherlands

http://www.controlled-trials.com/ISRCTN54386944/

A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain Phase III: Randomized, Parallel Assignment, Safety Study NCT00361504

Tapentadol (CG5503) PR; Oxycodone CR

OA, Hip; OA, Knee; Lower Back Pain; Pain

Comp 1122 Adt Sen

Oct-06 Jul-08 Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Grünenthal GmbH


Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan Phase III: Single Group Assignment, Safety/Efficacy Study NCT00212628

Minodronic acid hydrate

Involutional Osteoporosis

Comp 444 Adt Sen

F-

only

Jun-04 ? Jul-08

Ono Pharma; Astellas Pharma Inc


Flurbiprofen Tape for Treatment of Chronic Low Back Pain Phase II: RCT (placebo), Safety/Efficacy Study NCT00759330

Flurbiprofen Tape; Placebo Tape


Comp 120 Adt Sen

Oct-07 Jul-08 Teikoku Pharma USA


Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica RCT (placebo), Safety/Efficacy Study NCT00516009

Dexamethasone; Placebo

RADICULAR PAIN

Rec 40 Adt Sen

Aug-07 Jul-08 Ziv Hosp http://ClinicalTrials.gov/show/NCT00516009








69

Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain Phase IV: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00873730

Etanercept; Placebo


Comp 108 Adt Sen

Dec-06 Jun-08 Wyeth http://ClinicalTrials.gov/show/NCT00873730

Adalimumab in Severe and Acute Sciatica Phase II: RCT (placebo), Safety/Efficacy Study NCT00470509

Adalimumab (2 subcutaneous 40 mg injections on day 0 and 7)

Sciatica Comp 61 Adt Sen

May-05

Jun-08 Uni. Hosp, Geneva http://ClinicalTrials.gov/show/NCT00470509

A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets Prospective Study NCT00642837

Tramadol/ acetaminophen

Rheumatic Diseases: including Low back pain


Sep-07 May-08

Janssen Korea, Ltd., Korea


Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain Phase III: Randomized, Crossover Assignment, Safety/Efficacy Study NCT00594516

CG5503 IR / CG5503 ER; CG5503 ER / CG5503 IR


Nov-07 May-08

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Grünenthal GmbH


Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain. Phase IV: RCT (active), Efficacy Study NCT00290901

Tramadol Hydrochloride 50mg; Celebrex 200mg

Back Pain Comp 754 Adt Sen

Mar-06 Dec-06 Pfizer http://ClinicalTrials.gov/show/NCT00290901

Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis Phase III: RCT (placebo), Safety/Efficacy Study NCT00195819

Adalimumab (D2E7); Placebo


Comp 82 Adt Sen

Dec-03 Oct-04 Abbott http://ClinicalTrials.gov/show/NCT00195819







70


Chiropractic and Exercise Management of Spinal Dysfunction in Seniors Phase II/III: RCT (active) NCT01057706

Chiropractic; Behavioral: exercise

Neck Disability; Back Disability

Rec 300 Adt Sen

Jan-10 Aug-15 Northwestern Health Sciences Uni.; Health Resources and Services Administration


PRF Treatment for Patients With Chronic Lumbosacral Radicular Pain Compared to Conventional Medical Management RCT (historical), Efficacy Study NCT00991237

Pulsed Radiofrequency

Lumbosacral Radicular Syndrome

Not yet Rec

29 Adt Sen

Feb-10 Mar-14 Maastricht Uni. Medical Center; ZOL Hosp Genk Belgium; Sint Jozef Hosp Bornem en Willebroek Belgium


A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections RCT (active), Safety/Efficacy Study NCT01053273

Caudal Epidural Injection; Percutaneous adhesiolysis




Chiropractic and Exercise for Low Back Pain in Adolescents Phase II/III RCT (active), Efficacy Study NCT01096628

Chiropractic + Exercise

Low Back Pain Rec 184 Child Adt

Mar-10 Mar-13 Northwestern Health Sciences Uni.; Uni. of Western States


The effect of various combinations of naprapathic manual therapy for patients with neck pain and/or back pain RCT (active) ISRCTN92249294

Naprapathic manual therapy; Naprapathic manual therapy excluding spinal manipulation; Naprapathic manual therapy except stretching

Non-specific back pain; Non-specific neck pain

Active 1050 Adt Mar-10 Dec-12 The Scandinavian College of Naprapathic Manual Medicine


Efficacy of orthomanual treatment in addition to usual care in patients with chronic low back pain in an academic pain clinic population. RCT (active) NTR1818

Orthomanual treatment + usual care; usual care

Non-specific low back pain, Chronic

Active 100 Adt Sen?

Aug-09 Aug-12 EMGO Institute, The Netherlands










71

Radiofrequency Nerve Ablation Versus Sham to Treat Chronic Low Back Pain Caused by Sacroiliac Joint Dysfunction Observational: Prospective, Case-Crossover NCT01104051

Radiofrequency nerve ablation; sham

Sacroiliac Joint Dysfunction

Rec 39 Adt Sen

Apr-10 Apr-12 Coastal Orthopedics & Sports Medicine


Treatment of Chronic Thoracic and Neck and Upper Extremity Pain RCT (dose comparison), Safety/Efficacy Study NCT01071369

Thoracic and cervical interlaminar epidural injections; Drug: Xylocaine; Celestone


Active NR

240 Adt Sen



Treatment of Chronic Low Back and Lower Extremity Pain Randomized, Parallel Assignment, Safety/Efficacy Study NCT00681447

Lumbar Interlaminar Epidural




The effect of shared decision-making on the recovery of non-chronic low back pain in primary care. RCT (active) NTR1960

Shared decision making (patients & GP); Usual care

Non-chronic low back pain

Active 600 Adt Mar-10 Jan-12 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht


Effectiveness of a multidisciplinary intervention in subacute low back pain in the working population RCT ISRCTN21392091

Multidisciplinary intervention; Standard clinical practice

Sub-acute low back pain

Active 932 Adt Jan-09 Dec-11 La Marató de TV3 Foundation, Spain


A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP) RCT (placebo), Efficacy Study NCT01049074

Acupuncture Treatment; Sham acupuncture


Nov-08 Nov-11 Beijing Hosp of Traditional Chinese Medicine


Assess the Effectiveness of Pulse RadioFrequency in Patients With Chronic Lumbar Radicular Pain RCT (placebo), Safety/Efficacy Study NCT01117870

Pulsed RadioFrequency; Placebo

Chronic Lumbar Radicular Pain

Not yet Rec

32 Adt Sen

Jun-10 Aug-11 McMaster Uni. http://ClinicalTrials.gov/show/NCT01117870










72

Clinical Prediction Rule for Clinical Lumbar Instability Single Group Assignment, Efficacy Study NCT01085448

Core Stabilization Low Back Pain, Mechanical

Rec 60 Adt Mar-10 Aug-11 Drexel Uni. http://ClinicalTrials.gov/show/NCT01085448

Effects of Mattress Firmness on Pain in Patients With Chronic Low-Back Pain Crossover Assignment NCT01044121

Mattress Firmness Low Back Pain; Sleep Disruption

Rec 40 Adt Jan-10 Jul-11 Sleep To Live Institute; Duke Uni.


Traditional Chinese Medicine in Routine care of Orthopaedic Rehabilitation - sustainability and acceptance by patients of the German Pension Fund RCT (active) ISRCTN40932605

Traditional Chinese Medicine

Chronic back pain; Osteoarthritis

Active 520 Adt Jan-09 Jun-11 Refonet, Germany http://www.controlled-trials.com/ISRCTN40932605

Chiropractic Management of Chronic Lower Back Pain in Older Adults RCT (active), Efficacy Study NCT00475787

Spinal Manipulation Chronic Low Back Pain

Rec 216 Adt Sen

Apr-08 Jun-11 Department of Veterans Affairs


The effect of ultrasound as a treatment for long lasting low back pain. RCT (placebo) NTR2251

Continuous therapeutic ultrasound + semi-supervised exercise program; placebo ultrasound + semi-supervised exercise program


Active 50 Adt Sen?

May-10

May-11

Tehran University Medical School


Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis; a Randomized Clinical Trial Randomized, Parallel Assignment NCT00786981

Epidural steroid injection plus physical therapy; Epidural steroid injection

Lumbar Spinal Stenosis

Rec 80 Adt Sen

Apr-09 May-11

Franklin Pierce Uni.; Uni. of Colorado, Denver


Classification algorithm for low back pain. RCT (active) NTR1176

Classification algorithm; usual care


Active 150 Adt Sen?

Apr-08 Apr-11 VU University Medical Centre; EMGO Institute, The Netherlands












73

Dose of Spinal Manipulation for Chronic Low Back Pain Phase II/III: RCT (dose comparison), Efficacy Study NCT00376350

Spinal Manipulation; Light Massage; Pulsed Ultrasound


Mar-07 Mar-11 Uni. of Western States; National Center for Complementary and Alternative Medicine (NCCAM)


Does Magnetic Resonance Imaging (MRI) Improve Interventional Outcomes for Lumbosacral Radiculopathy? RCT (active), Efficacy Study NCT00826124

Epidural steroid injection; Magnetic Resonance Imaging (MRI)

Lumbosacral Radiculopathy

Active NR

131 Adt Sen

Jan-09 Feb-11 Johns Hopkins Uni.; Walter Reed Army Medical Center


Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks Single Group Assignment, Safety/Efficacy Study NCT00909272

Lumbar medial branch block; Ultrasound landmarks


25 Adt Jul-09 Jan-11 Hamilton Health Sciences




Range of conditions

6

including Back Pain; Fibromyalgia; Knee Pain; OA; Senile Osteoporosis and Shoulder Pain

Invite 728 Adt Sen

May-09

Dec-10 Uni. of Missouri-Columbia; National Library of Medicine (NLM)


Prognostic Value of Hyperexcitability of the Central Hypersensitivity in Patients With Acute Low Back Pain Observational: Prospective, Cohort Study NCT00892411

Parameters of central hypersensitivity; Spinal cord hyperexcitability; Descending modulation and cortical reorganization

Pain Measurement; Low Back Pain

Rec 140 Adt Sen

Feb-09 Dec-10 Uni. Hosp Inselspital, Berne


6 Acne Vulgaris; Allergic Rhinitis; Anxiety; Asthma; Prostatic Hyperplasia; Bursitis; Chronic Obstructive Pulmonary Disease; Cough; Coronary Artery Disease; Depression; Diabetes Mellitus;

Diarrhea; Gastroesophageal Reflux; Headache; HIV Infections; Hypothyroidism; Hyperlipidemia; Hypertension; Influenza; Sleep Initiation and Maintenance Disorders; Irritable Bowel Syndrome; Migraine Disorders; Obesity; Obstructive Sleep Apnea; Colonoscopy; Mammography; Sinusitis; Smoking Cessation; Tobacco Use Cessation; Menopause; Urinary Incontinence; Urinary Tract Infection; Vaccination; Vaginitis; Vertigo






74

Osteopathic Treatment of Low Back Pain Observational: Prospective, Cohort Study NCT00883987

Low Back Pain Rec 10 Adt Jun-09 Dec-10 Capital District Health Authority, Canada


Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients Phase II: RCT (placebo), Efficacy Study NCT00830596

HVLA-SM; LVVA-SM; light effleurage followed by SMT

Low Back Pain Rec 219 Adt Jul-07 Dec-10 Palmer College of Chiropractic; National Center for Complementary and Alternative Medicine


Chiropractic and Self-care for Back-Related Leg Pain RCT (active), Efficacy Study NCT00494065

Home exercise; Chiropractic Spinal Manipulative Therapy + Home exercise

Sub-acute and Chronic Back-related Leg Pain

Active NR

192 Adt Sen

Jun-07 Oct-10 Northwestern Health Sciences Uni.; Department of Health and Human Services


Individualized Chiropractic and Integrative Care for Low Back Pain RCT (active), Efficacy Study NCT00567333

Chiropractic care; Multidisciplinary, integrative care

Sub-Acute and Chronic Low Back Pain

Active NR

200 Adt Sen

Jun-07 Oct-10 Northwestern Health Sciences Uni.; Health Resources and Services Administration (HRSA); Berman Center for Outcomes and Clinical Research


Efficacy of Different Acupuncture Methods for Chronic Low Back Pain RCT (active), Efficacy Study NCT00758017

Acupuncture 1; Acupuncture 2


Rec 150 Adt Sen

Jan-09 Sep-10 Charite Uni., Berlin, Germany


Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy Phase III: RCT (active), Efficacy Study NCT00769626

Usual Care; Early Treatment

Back Pain; Low Back Pain

Rec 130 Adt Sep-08 Aug-10 Intermountain Health Care, Inc.








75

Assessment of Acupuncture to Improve Function, Exercise Capacity, and Pain Phase I: Single Group Assignment, Efficacy Study NCT00502619

Acupuncture and treadmill exercise


Rec 16 Adt Sep-07 Aug-10 VA Maryland Health Care System; Samueli Institute for Information Biology


The OSTEOPATHIC Trial: The OSTEOPAThic Health Outcomes In Chronic Low Back Pain Trial Phase III: RCT (placebo), Safety/Efficacy Study NCT00315120

Osteopathic manipulation + ultrasound physical therapy; Sham osteopathic manipulation + ultrasound physical therapy; Osteopathic manipulation + Sham ultrasound physical therapy; Sham osteopathic manipulation + sham ultrasound physical therapy


Aug-06 Jun-10 Uni. of North Texas Health Science Center; Osteopathic Research Center; National Institutes of Health (NIH); Osteopathic Heritage Foundations


Chiropractic for Back and Neck Pain in an Emergency Department Setting Phase I/II: RCT (placebo), Efficacy Study NCT00964717

Real Chiropractic; Sham Chiropractic

Back Pain; Neck Pain; Anxiety

Rec 90 Adt May-09

May-10

Assaf-Harofeh Medical Center


Acupuncture Analgesia in Relation to Psychiatric Comorbidity Phase III: RCT (placebo), Efficacy Study NCT00307788

Acupuncture Low Back Pain Active NR

60 Adt May-04

May-10

Brigham and Women's Hosp; National Center for Complementary and Alternative Medicine


Acupuncture for Back Pain: A Mixed Methods Observational Study Evaluating Patient Outcomes and Their Determinants Prospective, cohort study UKCRN ID 4857

Acupuncture Persistent back pain

N/K 500 Adt Sen

N/K May-10

Southampton University Hospitals NHS Trust








76

A Study to Evaluate Methods to Evaluate Back Pain Randomized, Parallel Assignment, Pharmacodynamics Study NCT01045993

Heat Device; placebo; Drug: marketed analgesic; sham

Pain Rec 60 Adt Jan-10 Apr-10 Wyeth http://ClinicalTrials.gov/show/NCT01045993

Implementing evidence based primary care for back pain Pre-post design ISRCTN55174281

Novel evidence-based clinical practice; current clinical practice

Low back pain Comp 1000 Adt Sen

Oct-07 Apr-10 Keele University, UK


Learning to Improve the Management of Back pain In the Community Single Group Assignment ISRCTN30420389

GP practice training Back pain Comp 1000 Adt Oct-07 Mar-10 Bournemouth University, UK


Improving the care for people with acute low-back pain by allied health professionals: a cluster randomised controlled trial RCT (active), Safety/Efficacy Study ACTRN12609001022257

Clinical guidelines underpinned by behavioural theory; usual care

Acute non-specific low back pain

N/K 2720 Adt Sen

Nov-09 > Feb-10

Monash University http://www.anzctr.org.au/trial_view.aspx?ID=320855

Assessment of Spinal Stability Observational: Cross-sectional, Case-Only NCT01060358

Method (non-surgical) to measure neuromuscular neutral zones

Spine Stability; Low Back Pain

Rec 25 Adt Aug-09 ? Jan-10

Uni. of Colorado, Denver


Acupuncture for Back and Neck Pain in an Emergency Room Setting Phase I/II: RCT (placebo), Efficacy Study NCT00859365

Real Acupuncture; Placebo Acupuncture; No intervention

Back Pain; Neck Pain; Anxiety; Range of Motion

Rec 90 Adt Jan-09 Jan-10 Assaf-Harofeh Medical Center


A Comparative Study: Non-Surgical Spinal Decompression and Spinal Manipulative Therapy- Utilizing a Quantifiable Musculoskeletal Functional Assessment Risk Analysis Tool (MSDR®) in Patients With Chronic Low Back Pain Randomized, Parallel Assignment NCT00732394

MSDR Chronic Low Back Pain

Rec 200 Adt Aug-08 Jan-10 MedAppraise, Inc. http://ClinicalTrials.gov/show/NCT00732394











77

Multiple Emergency Department Acupuncture Trials. (MEDACT) RCT (active) ACTRN12609000989246

Acupuncture; Pharmacologic treatment

Low back pain; Acute migraine; Ankle pain

N/K 505 Adt Sen

Dec-09 > Dec-09

Royal Melbourne Institute of Technology


Guideline Implementation in Physiotherapy Non-Randomized, Parallel Assignment NCT00962169

Behavioral and managerial; Behavioral and IT

Low Back Pain Rec 30 Child Adt Sen

Jul-09 Dec-09 Radboud Uni. http://ClinicalTrials.gov/show/NCT00962169

Assessing Patient Response to Therapeutic Exercise Based on Clinical Prediction Rule (CPR) for Spinal Manipulation Phase III: Randomized, Crossover Assignment, Efficacy Study NCT00916734

Spinal manipulation; MDT (McKenzie Method)


Nov-07 Dec-09 Daemen College http://ClinicalTrials.gov/show/NCT00916734

Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain RCT (active), Safety/Efficacy Study NCT00370994

Percutaneous adhesiolysis with hypertonic saline neurolysis (anesthetic, steroid, 10% sodium chloride solution)


Comp 320 Adt Sen

Jan-06 Dec-09 Pain Management Center of Paducah


Effects of Lumbosacral Joint Mobilization/Manipulation on Lower Extremity Muscle Neuromuscular Response Non-Randomized, Parallel Assignment, Efficacy Study NCT00601341

Lumbosacral joint manipulation; Lumbar passive range of motion; No active intervention

Knee Pain; Hip Pain; Ankle Pain; Lumbopelvic Pain

Rec 276 Adt May-05

Dec-09 University of Virginia


Measurement of Substance P in Saliva of Low Back Pain Patients Parallel Assignment (historical) NCT00735735

The taking of a saliva sample from each subject.


Feb-09 Oct-09 Kovacs Foundation http://ClinicalTrials.gov/show/NCT00735735

Soft Tissue Biomechanical Behavior During Acupuncture in Low Back Pain Single Group Assignment NCT00487266

Acupuncture Low Back Pain Rec 180 Adt Sep-06 Sep-09 National Center for Complementary and Alternative Medicine










78

Effect of Massage on Chronic Low Back Pain Phase II/III: RCT (active), Efficacy Study NCT00371384

Massage Chronic Low Back Pain (Non-specific, uncomplicated)

Active NR

399 Adt Aug-06 Sep-09 National Center for Complementary and Alternative Medicine


Chiropractic Dosage for Lumbar Stenosis Phase II: RCT (placebo), Safety/Efficacy Study NCT00527527

Flexion distraction; Placebo control

Lumbar Spinal Stenosis

Active, not Rec

60 Adt Sen

Sep-07 Aug-09 National University of Health Sciences; Foundation for Chiropractic Education and Research (FCER)


Education/Exercise and Chiropractic for Chronic Back Pain RCT (active), Efficacy Study NCT00561652

Chiropractic treatment + Education + Exercise; Education + Exercise;


Apr-08 Jul-09 Department of Veterans Affairs; Northwestern Health Sciences Uni.


Manual and Manipulative Therapy for Low Back Pain Randomized, Parallel Assignment, Efficacy Study NCT00632060

Manual / Manipulative Therapy (M/MT)

Low Back Pain Rec 100 Adt Feb-08 Jul-09 Samueli Institute for Information Biology


The Effects of Short Arc Banding Phase I/II: Single Group Assignment, Efficacy Study NCT00885001

Short Arc Banding Chronic Low Back Pain

Rec 30 Adt Apr-09 May-09

Logan College of Chiropractic


Early physiotherapy for acute lower back pain in health care workers UKCRN ID 3292

Early physiotherapy Low back pain Active NR

50 Adt N/K May-09

Southampton City Primary Care Trust


The Right Intervention for the Right Patient Randomized, Parallel Assignment, Efficacy Study NCT00459433

Biopsychosocial intervention

Low Back Pain Comp 300 Adt Oct-06 May-09

The Back Research Center, Denmark; European Commission










79

Z-Joint Changes in Low Back Pain Following Adjusting RCT (dose comparison), Efficacy Study NCT00284063

Neurtral MRI (lumbar spine); side posture MRI; Neutral MRI; low back adjustment; neutral MRI; Neutral MRI; low back adjustment; side posture MRI; Neutral MRI; side posture position; neutral MRI

Mechanical Low Back Pain

Comp 112 Adt Sen

Feb-06 ? May-09

National Uni. of Health Sciences


Changes in Cerebral Blood Flow in Patients Treated With Spinal Cord Stimulation for Low Back and Leg Pain Phase IV: Single Group Assignment, Safety/Efficacy Study NCT00418301

Precision Spinal Cord Stimulation and PET Scan

Pain; Low Back Pain; Leg Pain

Comp 15 Adt Sen

Jan-07 Apr-09 Boston Scientific Corporation


Driving out back pain in business drivers UKCRN ID 3293

? Process of care Back pain N/K 60 N/K N/K Apr-09 Loughborough University


Traditional Acupuncture and Myofascial Trigger Point Dry Needling and Acupressure for Chronic Low Back Pain RCT (active), Efficacy Study NCT00804089

Traditional needle acupuncture; Myofascial trigger point dry needling; Myofascial trigger point acupressure

Low Back Pain Rec 90 Adt Dec-08 Mar-09 Hermano Miguel Foundation; Ecuadorian Federation of Physiotherapy, Tungurahua Branch; Technical Uni. of Ambato


Cross-Disciplinary Workplace Intervention Strategy for Chronic Musculoskeletal Disorders RCT (active), Efficacy Study NCT00369135

Combined intervention

Back Pain; Neck Pain; MSK Abnormalities

Rec 120 Adt Mar-06 Feb-09 Institut Universitaire Romand de Sante au Travail


Unguided Sacroiliac Injection: Effect on Refractory Buttock Pain in Patients With Spondyloarthropathies Single Group Assignment, Safety/Efficacy Study NCT00829543

Guide-free sacroiliac corticosteroid injection

Spondyl-arthropathy

Invite 35 Child Adt

Sep-04 Feb-09 Tabriz Uni. http://ClinicalTrials.gov/show/NCT00829543








80

A pragmatic, single blind randomised controlled pilot study for professional kinesiology practice and back pain with initial feasibility study RCT (placebo) ISRCTN76057921

Kinesiology; Sham Kinesiology; Waiting list

Chronic and recurrent low back pain

Comp 150 Adt Sep-07 Jan-09 University of Southampton, UK


Efficacy and Cost: Benefit Ratio of 0, 1, and 2 Medial Branch Blocks for Lumbar Facet Joint Radiofrequency Denervation Randomized, Parallel Assignment, Efficacy Study NCT00484159

Radiofrequency denervation of medial branches + 0.5% bupivacaine + 2% lidocaine;


Feb-07 Jan-09 Johns Hopkins Uni. http://ClinicalTrials.gov/show/NCT00484159

The Effect of Chiropractic Manipulation on Spine-related Pain and Balance in Older Adults Single Group Assignment, Efficacy Study NCT00497718

Chiropractic Manipulation

MSK Equilibrium; Back Pain; Neck pain

Comp 75 Adt Sen

Feb-07 Dec-08 Cleveland Chiropractic College


Energy Specific Far Infrared Radiation Treatment for Sciatica Phase I: Single Group Assignment, Efficacy Study NCT00573807

Radiation: Far Infrared Radiation (5μm to 20μm wavelength)

Sciatica Active NR

2 Child Adt Sen

Jan-06 Dec-08 GAAD Medical Research Institute Inc.


Clinical Research on the Efficacy of Acupuncture Treatment in Chronic Low Back Pain NCT00815529

Acupuncture, Pak-sham needle

Chronic Low Back Pain; Acupuncture

Expand N/K Adult N/K ? Dec-08

Kyunghee Uni. Medical Center; Korea Health Industry Development Institute


A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain Phase I: Randomized, Parallel Assignment NCT00922220

Spinal manipulative therapy; Stationary bike; Lumbar extension exercise

Low Back Pain Comp 94 Adt Oct-04 Nov-08 Uni. of Florida http://ClinicalTrials.gov/show/NCT00922220

The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain RCT (active), Efficacy Study NCT00939107

Spinal manipulation; McKenzie exercises

Low Back Pain Comp 350 Adt Sep-03 Nov-08 Back and Rehabilitation Center, Copenhagen










81

Integrating Targeted MedlinePlus Health Prescriptions Into Clinic Practice Workflow Non-Randomized (historical), Efficacy Study NCT00634608

Health Information Prescription - MedlinePlus link

Range of conditions

7

including Back Pain; Osteoporosis (Senile); and Shoulder Pain

Active NR

400 Adt Sen

Feb-08 Oct-08 Uni. of Missouri-Columbia; National Library of Medicine (NLM)


Economic Evaluation of an Exercise Program After Multidisciplinary Rehabilitation in Patients With Chronic Low Back Pain Randomized, Parallel Assignment, Efficacy Study NCT00960583

Functional multidisciplinary rehabilitation; Exercise program; Routine follow-up


Comp 105 Adt Jan-05 Oct-08 Uni. of Lausanne http://ClinicalTrials.gov/show/NCT00960583

The Effect of Manipulations of the Lumbar Spine on Six Different Outcome Measures RCT (placebo), Safety/Efficacy Study NCT00739570

AAI signature IV AMCT


Jun-08 Aug-08 Universite du Quebec a Montreal


Algometer and Category II Pelvic Blocking and Cranial Protocol Randomized, Parallel Assignment NCT00649753

Category II Pelvic Blocking; Category II Pelvic Blocking and Cranial; Cranial Only

Pain; Sacroiliac Joint Dysfunction

Comp 40 Adt Mar-08 Aug-08 Logan College of Chiropractic


A randomised controlled trial of Neuro Emotional Technique for chronic low back pain sufferers. RCT (active) ACTRN12608000002381

Neuro Emotional Technique (NET); Sham NET


N/K 120 Adt Sen

Feb-08 > Aug-08

Macquarie University, Australia


A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain Single Group Assignment NCT00562562

Osteopathic manipulative treatment

Low Back Pain Rec 6 Adt Sep-07 Aug-08 Ohio Uni.; Collaborating institution: O'Bleness Memorial Hosp, Athens


7 Allergic Rhinitis; Asthma; Benign Prostatic Hypertrophy; Bursitis; Depression; Anxiety; Diabetes Mellitus; Esophageal Reflux; HIV Infections; Hyperlipidemia; Hypertension; Insomnia; Irritable

Bowel Syndrome; Obesity; Sinusitis; Symptomatic Menopause; Urinary Incontinence; Urinary Tract Infection; Vaginitis








82

Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain Phase IV: Single Group Assignment NCT00443781

Functional Anaesthetic Discography; Provocative discography


100 Adt Sen

Mar-07 ? Aug-08

Medtronic Spine LLC


Stepped Care for Depression and Musculoskeletal Pain Phase IV: RCT (active), Efficacy Study NCT00118430

Stepped Care; Antidepressants; Self-management program; Usual Care

Pain, back, hip or knee; Depression

Active, NR

500 Adt Sen

Sep-04 Aug-08 National Institute of Mental Health (NIMH)


Spinal Manipulative Therapy for Low Back Pain Phase IV: RCT (active), Efficacy Study NCT00294229

Manipulative therapy


102 Adt Apr-03 ? Aug-08

Uni. of Bern; Swiss Society for Manual Therapy; Uni. Hosp Inselspital, Berne; Wissen-schaftlicher Fonds WFR


Integration of the traditional Chinese medicine into the orthopedic rehabilitation: effects on pain and employment prognosis for patients with chronic back pain RCT ISRCTN59155637

Traditional Chinese Medicine + orthopedic rehabilitation; orthopedic rehabilitation

Chronic back pain

Comp 270 Adt Jan-06 Jun-08 Refonet, Germany http://www.controlled-trials.com/ISRCTN59155637

Study Care Versus Usual Care for Acute Mechanical Lower Back Pain RCT (active), Pharmacokinetics Study NCT00135239

Study care; Usual care

Low Back Pain, Mechanical

Comp 88 Adt Jan-06 Jun-08 Uni. of British Columbia


Exercise and manual auricular acupuncture: a single-blind, feasibility, randomised controlled trial exploring the effectiveness of a combined approach for chronic low back pain RCT ISRCTN94142364

Auricular acupuncture + individually tailored, supervised exercise; individually tailored supervised exercise


Comp 80 Adt Jun-06 May-08

University of Ulster, UK










83


Assessment of SpondyloArthritis Society (ASAS) Classification and Diagnostic Criteria for Early Axial Spondyloarthritis (SpA) Prospective, Cohort Study NCT00328068

Spondylo-arthritis; Spondyl-arthropathy; Spondylitis, Ankylosing

Rec 992 Adt Sen

Jul-06 Jun-13 Charite Uni., Berlin, Germany


Cytology Study of Cells From Patients With Low Back Pain Prospective, Case-Only NCT01089478


Apr-05 Apr-13 Texas Tech Uni. Health Sciences Center


Low Back Pain Illness Trajectories: The BeBack Long Term Follow Up Study Cohort Study UKCRN ID 8184

Low back pain Not yet rec

810 Adt Sen

N/K May-12

Keele University http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=8184

Study of Cells From Spinal Cavity of Patients With Low Back Pain Prospective, Case-Only NCT01089491


Mar-10 Dec-11 Texas Tech Uni. Health Sciences Center


Association Between Low Back Pain and Quality of Sleep Prospective NCT00906152

Quality of Sleep; Subacute or Chronic Low Back Pain; Disability; Catastrophizing; Depression


Sep-09 Sep-11 Kovacs Foundation http://ClinicalTrials.gov/show/NCT00906152

The Influence of Different Factors on Workers' Disability Due to Low Back Pain Prospective NCT00667316

Low Back Pain Rec 7200 Adt Feb-08 Mar-11 Kovacs Foundation http://ClinicalTrials.gov/show/NCT00667316

Back Pain Prevalence in Wheelchair Users and Associated Risk Factors Cross-Sectional NCT00477568


Nov-07 Dec-10 Kovacs Foundation; Instituto de Asuntos Sociales y Deportes de Mallorca










84

The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain Prospective, Cohort Study NCT00502333


Rec 1400 Adt Sen

Nov-06 Dec-10 Kovacs Foundation http://ClinicalTrials.gov/show/NCT00502333

Patterns of Cerebral Activation to Innocuous and Noxious Heat Stimulations in Neuropathic Pain Cross-Sectional, Cohort NCT00713024

Neuropathic Pain

Rec 150 Adt Sen

Jan-08 Dec-10 National Taiwan Uni. Hosp


Spinal Cord Stimulation Research Study Prospective, Case-Only NCT00768872

Chronic Low Back and Leg Pain

Rec 33 Adt Sen

Oct-08 Oct-10 MedtronicNeuro http://ClinicalTrials.gov/show/NCT00768872

Diagnostic accuracy of recently proposed criteria for inflammatory back pain (IBP) in suspected ankylosing spondylitis (AS) and early axial spondyloarthritis (axial SpA) Prospective

Inflammatory back pain; Chronic back pain; Ankylosing spondylitis; Axial spondyloarthritis

Active 550 Adt Sen

Sep-08 Aug-10 Charite – University Medicine Berlin, Germany


Clinical assessment of patients with low back-related leg pain in primary care. A consensus study Cross-sectional UKCRN ID 8065

Sciatica; Low back pain; Leg pain

Active 120 Adt Sen

N/K Aug-10 Keele University http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=8065

Prevalence of Back Pain and Associated Risk Factors in 10-12 Year Old Schoolchildren Cross-Sectional NCT00666419

Measurement, weight, and muscle strength test

Low Back Pain Rec 8000 Child Sep-06 Jun-10 Kovacs Foundation; Universitat de les Illes Balears


Prevalence of MODIC Changes in Subjects With and Without Low Back Pain Cross-Sectional NCT00479063

Low Back Pain Rec 292 Adt May-08

May-10

Kovacs Foundation http://ClinicalTrials.gov/show/NCT00479063

WHODAS-II for Patients With Nonspecific Low Back Pain Control: Uncontrolled; Single Group Assignment, Efficacy Study NCT00479245

Set of questionnaires (respondent)


Apr-07 May-10

Kovacs Foundation http://ClinicalTrials.gov/show/NCT00479245











85

Lumbar Stenosis Outcomes Research (LUSTOR) Phase IV Prospective, Cohort Study NCT00638443

Neurogenic Intermittent Claudication; Lumbar Spinal Stenosis

Rec 37 Adt Sen

Mar-08 May-10

Uni. of Rochester; Pfizer


Association of Modic Changes With Chronic Low Back Pain Cross-Sectional NCT00478868

Low Back Pain Rec 219 Adt May-08

Apr-10 Kovacs Foundation http://ClinicalTrials.gov/show/NCT00478868

Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain (Study P05320) Prospective, Cohort Study NCT00726765

Spinal Spondylo-arthropathies; Axial Spondyloarthritis

Active NR

1000 Adt Sen

Jun-08 Apr-10 Schering-Plough http://ClinicalTrials.gov/show/NCT00726765

Screening of Instability of the Spinal Column With Spinal Mouse® and x-Ray Cross-sectional, Case-Only NCT00837538

Instability of Lumbar Spine

Not yet Rec

100 Adt Sen

Feb-09 Feb-10 JyväskyläCentral Hosp


Low Back Pain Illness Trajectories. The BaRNS Long Term Individual and Family Follow Up Study Cohort Study UKCRN ID 7005

Low back pain Active NR

358 Adt Sen

N/K Dec-09 Keele University http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=7005

Rehabilitation of Dynamic Muscle, Back Pain and Postural Balance Retrospective, Case Control NCT01011270

Low Back Pain Invite 82 Adt

M-only

Jul-09 Nov-09 Universidade Castelo Branco


Assessment of a Specific Neurophysiological Brain Pattern in Patients Suffering From Chronic Back Pain Prospective, Case Control NCT00744575

Back Pain Active NR

72 Adt Sen

Aug-08 Oct-09 Uni. Hosp Freiburg http://ClinicalTrials.gov/show/NCT00744575

Changing perceptions of work ability in people with low back pain: feasibility and economic evaluation (phase 2) UKCRN ID 7086


50 N/K N/K Oct-09 University of Nottingham












86

Validating PROMIS Instruments in Back and Leg Pain Prospective, Case-Only NCT00784251

Leg Pain; Back Pain

Rec 185 Adt Sen

Jul-08 Jul-09 National Institutes of Health (NIH)


Genetic Determinants of Ankylosing Spondylitis Severity NCT00056849


Rec 2000 Adt Sen

Mar-03 ? Jul-09

National Institute of Arthritis and Musculoskeletal and Skin Diseases


Genetic Determinants of Ankylosing Spondylitis Severity - Longitudinal Study NCT00056719


Rec 2000 Adt Sen

Mar-03 ? Jul-09

National Institute of Arthritis and Musculoskeletal and Skin Diseases


Dunedin Acute Back Pain Study: Identifying patients at risk to develop chronic low back pain Prospective, Longitudinal Study ACTRN12608000520336

Acute low back pain

N/K 800 Adt Nov-08 > May-09

University of Otago; South Link Health Inc, Dunedin, New Zealand


Spinal Cord Stimulation Research Study Prospective NCT00737581

Chronic Low Back and Leg Pain.

Comp 30 Adt Sen

Aug-08 Apr-09 MedtronicNeuro http://ClinicalTrials.gov/show/NCT00737581

An investigation into the predictive relationships between physical activity and recovery in a population with acute low back pain Prospective, Longitudinal Study ACTRN12609000282280

Acute low back pain

N/K 80 Adt Mar-08 > Mar-09

University of Otago, New Zealand


French Validation Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) Questionnaire Prospective, Cohort Study NCT00706043

Acute Low Back Pain; Chronic Low Back Pain

Not yet Rec

120 Adt Jun-08 ? May-08

Cliniques universitaires Saint-Luc- UniversitÃ© Catholique de Louvain


Causes of Low Back Pain in Nurses in Israeli Hospitals Prospective, Cohort Study NCT00681096


350 Adt Sen

Jun-08 ? May-08

Hillel Yaffe Medical Center


Changing perceptions of work ability in people with low back pain: feasibility and economic evaluation UKCRN ID 5122


30 N/K N/K Mar-09 University of Nottingham














87

A6: HIP PAIN



Start Date

End Date

Sponsors URL


Developing an active management booklet for hip and knee pain: an interventional single centre randomised controlled trial RCT (active) ISRCTN24554946

New educational booklet; Patient information regarding osteoarthritis

Hip pain; Knee pain (inclusion not dependent on diagnosis of OA)

Comp 200 Adt Sen

Jan-09 Jun-09 Cardiff University, UK.



Osteonecrosis of the Hip and Bisphosphonate Treatment Phase IV: RCT (placebo), Efficacy Study NCT00781261

Zoledronic Acid; Placebo

Osteonecrosis Rec 120 Adt Aug-09 Dec-13 University of Sydney; Novartis


Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome Phase IV: RCT (placebo), Efficacy Study NCT00863889

Depomedrol injection; Lidocaine, Marcaine

Bursitis Rec 50 Child Adt Sen

Mar-09 Feb-10 Emory University http://ClinicalTrials.gov/show/NCT00863889





Rec 276 Adt May-05








88

Stepped Care for Depression and Musculoskeletal Pain Phase IV: RCT (active), Efficacy Study NCT00118430



Active, NR

500 Adt Sen




Development of Outcome-Measures for Physically Active Patients With Hip and Groin Pain Prospective NCT00716729

Hip Disability; Groin Disability

Not yet Rec

150 Adt Sen

Jan-09 Dec-10 Amager Hospital; Lundbeck Foundation


Prevalence of Femoroacetabular Impingement in Asymptomatic Patients Prospective Cohort Study NCT00606047

Femoroacetabular Hip Impingement Syndrome

Active, NR

200 Child Adt Sen

Aug-07 ? Sep-09

Ottawa Hospital Research Institute


A7: KNEE PAIN



Start Date

End Date

Sponsors URL


A single centre non-randomised interventional trial of physiotherapy-led exercise versus care as usual for knee pain in older adults in primary care Non-randomized, parallel assignment ISRCTN23294263

Physiotherapy-led exercise; usual care

Knee pain or stiffness

Comp 30 Adt Sen

Sep-09 May-10

Keele University http://www.controlled-trials.com/ISRCTN23294263






89

Developing an active management booklet for hip and knee pain: an interventional single centre randomised controlled trial RCT (active) ISRCTN24554946

New educational booklet; Patient information regarding osteoarthritis

Hip pain; Knee pain (inclusion not dependent on diagnosis of OA)

Comp 200 Adt Sen

Jan-09 Jun-09 Cardiff University, UK.



Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy Phase II: Single Group Assignment, Safety/Efficacy Study NCT01111773

Heated Lidocaine and Tetracaine Topical Patch

Patellar Tendinopathy

Not yet Rec

20 Adt Sen

May-10

Sep-10 ZARS Pharma Inc. http://ClinicalTrials.gov/show/NCT01111773

A randomised controlled trial on the effect of zolendronic acid versus placebo on the amount of knee pain in patients with bone marrow oedema-associated knee pain. RCT (placebo) ACTRN12609000399291

Zolendronic acid IV; Saline IV

Knee pain Rec 60 Adt Sen

May-09

May-10

Menzies Research Institute, Australia


Study Into the Effect of Ibandronate for the Treatment of Bone Marrow Edema in Relation to Spontaneous or Non-Traumatic Osteonecrosis of the Knee: A Randomized Double-Blind, Placebo-Controlled Trial Phase III: RCT (placebo), Efficacy Study NCT00532220

Ibandronate IV; Placebo

Osteonecrosis of the Knee; Bone Marrow Edema of the Knee

Rec 30 Adt Sen

Dec-07 May-09

University Hospital, Basel, Switzerland





Term 330 Adt Sen










90

Ibuprofen plus paracetamol in knee pain RCT (active) ISRCTN77199439

Ibuprofen 400mg; Paracetamol 100mg; Ibuprofen 200mg + Paracetamol 500mg

Knee pain Comp 800 Adt Sen

Jun-07 May-08

RB Corporate Services LTD, UK



Treatment of Medial Compartmental Osteoarthritis Grade 1-4 (According to Kellgren-Lawrence) or Osteonecrosis With TomoFix™ Small or Conservatively Prospective, Cohort Study NCT01048710

High tibial osteotomy; conservation treatment

Osteoarthritis, Knee; Osteonecrosis

Rec 148 Adt Sen

Jul-09 Feb-16 AO Clinical Investigation and Documentation; Synthes Inc.


The effect of acupuncture on pain and physical function in patients with chronic knee pain: a randomised placebo-controlled trial. RCT (placebo), Efficacy Study ACTRN12609001001280

Needle Acupuncture; Laser Acupuncture; Sham laser acupuncture; Sham needle acupuncture

Chronic knee pain

Active 280 Adt Sen

Dec-09 > Dec-10

The University of Melbourne, UK




Range of conditions

8

including Back Pain; Fibromyalgia; Knee Pain; Osteoarthritis; Senile Osteoporosis; and Shoulder Pain

Invite 728 Adt Sen

May-09

Dec-10 University of Missouri-Columbia; National Library of Medicine (NLM)


8 Acne Vulgaris; Allergic Rhinitis; Anxiety; Asthma; Prostatic Hyperplasia; Bursitis; Chronic Obstructive Pulmonary Disease; Cough; Coronary Artery Disease; Depression; Diabetes Mellitus;

Diarrhea; Gastroesophageal Reflux; Headache; HIV Infections; Hypothyroidism; Hyperlipidemia; Hypertension; Influenza; Sleep Initiation and Maintenance Disorders; Irritable Bowel Syndrome; Migraine Disorders; Obesity; Obstructive Sleep Apnea; Colonoscopy; Mammography; Sinusitis; Smoking Cessation; Tobacco Use Cessation; Menopause; Urinary Incontinence; Urinary Tract Infection; Vaccination; Vaginitis; Vertigo







91




Rec 276 Adt May-05



A randomised controlled trial to evaluate the effectiveness of insoles to treat anterior knee (patella femoral) pain RCT ISRCTN84641129

Orthaheel® regular; Sham insole

Anterior knee pain

Comp 100 Adt Mar-08 Jul-09 SSL International, UK


Stepped Care for Depression and Musculoskeletal Pain Phase IV: RCT (active), Parallel Assignment NCT00118430



Active, NR

500 Adt Sen




The course of knee pain and knee osteoarthritis in community-dwelling adults aged 50 years and over. 6-year follow-up of the Clinical Assessment Study – Knee (CAS-K). Cohort study UKCRN ID 6083

Knee pain; Knee osteoarthritis

Open 835 Adt Sen

N/K Mar-10 Keele University, UK


How are decisions made about self-care for knee pain and disability? UKCRN 5137

Knee pain and disability

Active NR

30 N/K N/K Apr-09 Keele University, UK


Knee Pain Progression and Risk Factors UKCRN ID 5640

Knee pain Active NR

5479 N/K N/K Aug-08 University of Nottingham


Public Health models of prevention of knee pain and disability in older adults UKCRN ID 4224

Knee pain and disability

Active NR

40 N/K N/K Jun-08 Keele University, UK




92

A8: FOOT, ANKLE & TOE PAIN

Title Phases: study designs (control) CT ID


Start Date

End Date

Sponsors URL

Device

Heel Cushion for Plantar Fasciitis Phase III: RCT (active), Efficacy Study NCT01017406

PSU heel cushion + plantar fascia specific stretching exercise

Plantar Fasciitis Not yet Rec

160 Child Adt

Jan-10 Apr-12 Prince of Songkla University


A multicentre randomised controlled trial to determine the efficacy of a simple pressure-relieving insole compared to a sham insole RCT (placebo) ISRCTN02824122

Pressure relieving insoles; sham insole

Scleroderma; Foot pain; Foot problems

Active 140 Adt Sen

Jul-10 Dec-11 University of Leeds, UK


Effectiveness of extracorporeal shock wave therapy in patients with proximal plantar fasciitis RCT ISRCTN49594569

Radial extracorporeal shockwave therapy – 3 or 6 sessions; No active treatment

Chronic plantar fasciitis

Active 68 Adt Sep-09 Sep-11 The Hong Kong Polytechnic University


Efficacy of customised foot orthoses in improving pain, function and activity in people with Achilles tendinopathy undergoing an eccentric calf muscle exercise program RCT (placebo), Efficacy Study ACTRN12609000829213

Custom foot orthoses + eccentric exercise; Sham foot orthoses + eccentric exercise

Achilles tendinopathy

Active 140 Adt Jul-09 > Jul-10


Effectiveness of radial shock wave treatment or tissue-specific plantar fascia-stretching in patients with chronic plantar heel pain RCT ISRCTN11644582

Radial shock wave therapy (RSWT); Plantar fascia-specific stretching (PFSS); RSWT + PFSS

Plantar fasciopathy

Comp 250 Adt Sen

Jul-07 Jan-10 OrthoTrauma Evaluation Centre, Germany











93

A Randomized Controlled Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain Randomized, Factorial Assignment, Efficacy Study NCT00765843

Orthoses Plantar Fasciitis Rec 300 Adt Sen

Oct-08 > Oct-09

Rosalind Franklin University of Medicine and Science; Advocate Health Care


A randomized controlled trial to evaluate the effectiveness of insoles to treat plantar heel pain RCT (placebo) ISRCTN47272667

Orthaheel® regular; Orthaheel® gel heel pad; Sham insole

Plantar heel pain Comp 150 Adt Mar-08 Jul-09 SSL International, UK


Plantar Fasciitis Treated With Dynamic Splinting RCT (active) NCT00650884

Ankle Dorsiflexion Dynasplint System

Plantar Fasciitis Comp 66 Adt Sen

Feb-08 Jan-09 Dynasplint Systems, Inc.


Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial RCT (active) NCT00717691

Metatarso-phalangeal Extension Dynasplint System; Standard of Care

Hallux Limitus Comp 50 Adt Sen

Jul-08 Dec-08 Dynasplint Systems, Inc.


Clinical Evaluation of Placement of Radiofrequency-Based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis Phase IV: Single Group Assignment, Efficacy Study NCT00420875

TOPAZ MicroDebrider

Plantar Fasciosis, Achilles Tendinosis

Wtdwn 90 Adt Jun-07 ? Oct-08

ArthroCare Corporation


Bracing and Strengthening for Posterior Tibial Tendon Dysfunction Phase II: RCT (placebo), Efficacy Study NCT00756457

Bracing; Strengthening exercises

Posterior Tibial Tendon Dysfunction

Comp 50 Adt Sen

Jul-07 Sep-08 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Plantar Fascia-Specific Stretching (PFSS) versus Radial Shock Wave Therapy (SWT) as Initial Treatment of Plantar Fasciopathy RCT (active) ISRCTN03438342

Plantar Fascia-Specific Stretching; Radial Shock Wave Therapy

Plantar Fasciopathy

Comp 100 Adt Sen

Aug-05 Aug-08 OrthoTrauma Evaluation Centre, Germany











94

Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction Phase I: RCT (active) NCT00279630

Orthoses and Behavioural: Exercise

Tendinopathy Rec 45 Adt Sen

Jun-02 Aug-08 University of Southern California


Plantar Fasciosis Treatment Using Coblation Phase IV: RCT (active), Efficacy Study NCT00189592

ArthroCare TOPAZ™ MicroDebrider™ using Coblation; Surgical Fasciotomy

Plantar Fasciosis; Plantar Fasciitis

Comp 45 Adt Sen

Aug-05 Jun-08 ArthroCare Corporation


Drugs including biological

Achilles Tendinopathy Management: a randomised controlled trial comparing platelet-rich plasma with an eccentric loading programme RCT ISRCTN95369715

Platelet Rich Plasma injection; eccentric loading exercise programme

Achilles tendinopathy

Active 20 Adt Sen

Feb-10 Feb-12 University of Warwick


Comparison of oral prednisolone and oral indometacin in the treatment of acute gout-like arthritis: a multicentre double-blind randomised trial RCT ISRCTN45724113

Prednisolone; Indometacin

Gouty arthritis Active 400 Adt Sen

Jan-10 Dec-11 Health, Welfare and Food Bureau, Hong Kong


PRP to Treat Plantar Fasciitis Phase IV: RCT (active), Efficacy Study NCT00758641

PRP obtained with GPS; Kenacort 40 mg/ml triamcinolon acetonide

Plantar Fasciitis Rec 120 Adt Sen

Sep-09 Dec-11 Biomet, Inc.; St. Elisabeth Hospital, Tilburg, Netherlands; Diaconessenhuis Leiden Netherlands; Biomet Nederland BV









95

A double blind, randomised, placebo controlled, multicentre trial of Anti-Tumour Necrotising Factor alpha (Anti-TNFα) chimeric monoclonal antibody (infliximab, Remicade®) in combination with methotrexate in patients with very early inflammatory arthritis RCT ISRCTN21272423

Symptomatic therapy + methotrexate + infliximab; Symtomatic therapy + methotrexate + placebo; Symptomatic therapy + placebo

Early arthritis (hand or foot involvement)

Active 200 Adt Sen

Sep-07 Sep-11 Medical Unviersity of Vienna, Austria


Treatment of Plantar Fasciitis With Platelet Rich Plasma RCT (active), Efficacy Study NCT01127672

Platelet rich plasma; Corticosteroid injection

Plantar Fasciitis Not yet Rec

50 Adt Sen

May-10

May-11

Loma Linda University


Ultrasound guided corticosteroid injection for plantar fasciitis: a randomised controlled trial RCT (placebo), Efficacy Study ACTRN12610000239066

Ultrasound guided dexamethasone sodium phosphate injection; Ultrasound guided saline injection

Plantar fasciitis Not yet Rec

80 Adt Sen

May-10

> Aug-10


NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control Leg Stiffness and Functional Recovery in Athletes Phase IV: RCT (active), Efficacy Study NCT00792376

Etoricoxib; Diclofenac

Achilles Tendinopathy

Not yet Rec

56 Adt

M-only

Jan-09 Apr-10 Argentine Tennis Association


Placebo-Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy Phase IV: RCT (placebo), Efficacy Study NCT00377910

Aethoxysclerol Chronic Achilles Tendinopathy

Rec 48 Adt Sen

Feb-07 Feb-10 Northern Orthopaedic Division, Denmark; University of Aarhus


Study to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis Phase II/III: RCT (placebo), Safety/Efficacy Study NCT00447876

Botulinum type A toxin (Dysport®)

Chronic Plantar Fasciitis

Comp 40 Adt Sen

Jul-05 Apr-09 Ipsen http://ClinicalTrials.gov/show/NCT00447876









96

Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis Phase III: RCT (placebo), Safety/Efficacy Study NCT00642382

Agilus; Normal saline

Osteoarthritis Term 17 Adt Sen

Apr-08 Dec-08 Carticept Medical, Inc


The effectiveness of intra-articular hyaluronan (Synvisc®) for the treatment of osteoarthritis affecting the first metatarsophalangeal joint of the foot (hallux limitus) RCT (placebo), Efficacy Study ACTRN12607000654459

Hylan GF-20 injection; Saline

OA, 1st

metatatarso-phalangeal joint

N/K 150 Adt Sen

Mar-08 Sep-08 La Trobe University, Australia


Randomised Clinical Trial of Prolotherapy Injections and Eccentric Loading Exercises for Painful Achilles Tendinosis RCT ACTRN12607000276459

Prolotherapy injection + eccentric exercise; eccentric exercise

Achilles Tendinosis

N/K 144 Adt Sen

Jun-07 Jun-08 Griffith University, Australia



Effectiveness of Podiatry on Plantar Pain Phase IV: RCT (active), Efficacy Study NCT00888394

Chiropody; Device:

Basic orthesis; Advantage orthesis; Chiropody and Advantage orthesis

Heel Pain; Plantar Fasciitis; Plantar Pain

Active, NR

312 Adt Sep-09 May-11

University of Malaga


Hyperpronation and Foot-Pains Randomized, Parallel Assignment, Safety/Efficacy Study NCT00736138

Training and pellots?

Arthrosis in Knee Rec 50 Adt Sen

Jan-07 Dec-10 Northern Orthopaedic Division, Denmark


Pathological processes and candidate interventions in mechanically induced foot pain UKCRN ID 6050

N/K Foot pain Active 60 N/K N/K May-10

Chapel Allerton Hospital, UK


Treatment of forefoot problems in the elderly: a randomised controlled trial of standardised shoe advice versus podiatric treatment. RCT (active) NTR2212

Podiatric treatment; Shoe advice education

Forefoot pain Active 200 Adt Sen

Mar-10 Mar-13 EMGO Institute, The Netherlands













97

Multiple Emergency Department Acupuncture Trials. (MEDACT) RCT (active) ACTRN12609000989246

Acupuncture; Pharmacologic treatment

Low back pain; Acute migraine; Ankle pain

N/K 505 Adt Sen

Dec-09 > Dec-09

Royal Melbourne Institute of Technology





Rec 276 Adt May-05




The Clinical Assessment Study of the Foot (CAS-F) Cohort Study UKCRN ID 8257

Foot pain Not yet Rec

5000 Adt Sen

N/K Sep-13 Keele University, UK







98

A9: FIBROMYALGIA



Start Date

End Date

Sponsors URL


Exercise-based Motivational Interviewing for Fibromyalgia RCT (placebo), Efficacy Study NCT00573612

Attention Control Counseling; Motivational Interviewing

Fibromyalgia Rec 200 Adt Dec-07 Dec-12 Indiana University http://ClinicalTrials.gov/show/NCT00573612

Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia Phase II: RCT (active), Efficacy Study NCT00925431

Lifestyle Modification; Supportive education

Fibromyalgia; Obesity

Rec 80 Adt Aug-09 Dec-11 University of Utah http://ClinicalTrials.gov/show/NCT00925431

Improving Quality of Life of Fibromyalgia Patients RCT (active), Efficacy Study NCT00715195

Plurifocal educational program; Information

Fibromyalgia Rec 100 Adt Sep-07 Dec-11 Assistance Publique - Hopitaux de Paris; Fondation de France


Drug and Talk Therapy for Fibromyalgia Phase IV: RCT (dose comparison), Efficacy Study NCT01038323

CBT + Milnacipran; CBT + placebo; Educational + milnacipran

Fibromyalgia Rec 48 Adt Dec-09 Nov-11 Indiana University; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Influence of Pain physiolgy Education on the Pain Inhibition in Fibromyalgia. RCT (active) NCT00857740

Education Fibromyalgia Rec 50 Adt Mar-09 Mar-11 Vrije Universiteit Brussel


Effect of One Week Self-management Program in Patients With Fibromyalgia Randomized, Parallel Assignment, Efficacy Study NCT01035125

Self-management program

Fibromyalgia Rec 150 Adt Sen

Dec-08 Mar-11 Revmatis-mesykehuset AS








99

Use of guided imagery in patients diagnosed with fibromyalgia: effects on pain, self-efficacy and functional status. RCT (active) NTR2172

Guided imagery; group sessions

Fibromyalgia Active 70 N/K Nov-09 Dec-10 Fonds NutsOhra http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2172

A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia Randomized, Parallel Assignment, Efficacy Study NCT01046370

Amygdala Retraining Program

Chronic Fatigue Syndrome; Chronic Fatigue; Fibromyalgia

Invite 30 Adt Oct-09 Jul-10 Mayo Clinic http://ClinicalTrials.gov/show/NCT01046370

Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia Phase II/III: RCT (placebo), Efficacy Study NCT00321451

CBT for insomnia; Pseudo-desensitization procedure; Usual care

Fibromyalgia; Sleep Initiation and Maintenance Disorders

Rec 111 Adt May-06

Jul-10 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Subgroups of Fibromyalgia Syndrome (FMS): Symptoms, Beliefs, and Tailored Treatment Phase II: Randomized, Parallel Assignment NCT00762125

CR+ST; ET; AC treatment

Fibromyalgia Rec 235 Adt

F-only

Dec-05 Jun-10 National Institutes of Health (NIH)


Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia RCT (active), Efficacy Study NCT00383084

Lifestyle physical activity (LPA); Fibromyalgia education

Fibromyalgia Rec 160 Adt Sep-06 Jun-10 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Yoga for Fibromyalgia RCT (historical), Efficacy Study NCT00966732

Yoga of Awareness Program

Fibromyalgia Active, NR

56 Adt Sen

F-

only

Oct-09 Jun-10 Oregon Health and Science University


Clinical trial examining effects of Monosodium glutamate (MSG) on Irritable Bowel Syndrome (IBS) and Fibromyalgia (FM) RCT (placebo), Safety Study NCT00829218

Glutamate additive-free diet; Placebo diet

Irritable Bowel Syndrome; Fibromyalgia

Active, NR

60 Adt Sen

Jan-09 May-10

Oregon Health and Science University; University of Arizona










100

Nondrug Treatment Programs for Adults With Fibromyalgia Phase II: RCT (active), Efficacy Study NCT00088777

Behavioral coping skills training + physical therapy; Stress management education + physical therapy

Fibromyalgia Rec 300 Adt Jan-05 Apr-10 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol] RCT (active), Efficacy Study NCT00550966

Psychoeducative program in fibromyalgic patients

Fibromyalgia Invite 109 Adt Sen

Sep-07 Feb-10 Institut Catala de Salut


Effectiveness of the psychological and pharmacological treatment of catastrophisation in patients with fibromyalgia: a controlled randomised trial RCT ISRCTN10804772

Psychological intervention including CBT; Pregabalin (with duloxetine if necessary); usual care

Fibromyalgia Comp 180 Adt Sep-08 Dec-09 The Carlos III Health Institute, Spain


Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia RCT (active), Safety/Efficacy Study NCT00643006

Physical exercise; Active comparator: low intensive exercise

Physical Function Rec 70 Adt

F-only

Jan-08 Dec-09 Göteborg University http://ClinicalTrials.gov/show/NCT00643006

Comparative effect of two supervised exercise programs on key health outcomes in women with fibromyalgia syndrome RCT ISRCTN43742447

Aerobic exercise sessions; Aerobic and muscle strengthening exercise sessions

Fibromyalgia Comp 54 Adt Sen

Sep-07 Dec-09 University of Seville, Spain


Stretching and Strengthening Exercise in Fibromyalgia Patients Randomized, Parallel Assignment NCT01029041

Strengthening Exercises; Stretching exercises

Fibromyalgia Syndrome

Comp 63 Adt

F-only

Aug-07 Nov-09 University of Sao Paulo General Hospital


A Computer-Based Intervention for Medically Unexplained Physical Symptoms RCT (placebo), Efficacy Study NCT00468013

Resilience Building Exercises; Journaling

Fibromyalgia; Irritable Bowel Syndrome; Chronic Fatigue Syndrome

Active, NR

60 Adt Sen

Mar-07 Sep-09 University of Medicine and Dentistry New Jersey











101

A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia Phase IV: RCT (active), Efficacy Study NCT00965601

Cognitive Behavioral Therapy

Fibromyalgia Comp 30 Adt

F-only

Jul-08 Aug-09 Indiana University http://ClinicalTrials.gov/show/NCT00965601

Tai Chi Mind-Body Therapy for Fibromyalgia RCT (placebo), Safety/Efficacy Study NCT00515008

12-week Tai Chi Program.; 12-week Stretching and Wellness Education Program


60 Adt Sen

Jun-07 May-09

Tufts Medical Center; National Center for Complementary and Alternative Medicine (NCCAM); American College of Rheumatology Research and Education Foundation


Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain Phase II: RCT (placebo), Efficacy Study NCT00176163

Operant behavioral treatment; Drug: THC

Fibromyalgia; Back Pain

Comp 240 Adt Sen

Aug-05 May-09

University of Heidelberg, Germay


Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial RCT (active), Efficacy Study NCT00437411

Affective Self-Awareness workshop


66 Adt Sen

Apr-07 Apr-09 University of Michigan; St. John Providence Hospital; Blue Care Network of Michigan


Sleep intervention in patients with fibromyalgia RCT ISRCTN87743899

Psychological intervention + current practice; current practice.

Fibromyalgia Comp N/K N/K Jul-06 Jan-09 Department of Health, UK


Cognitive Behavioral Therapy Trial in Fibromyalgia Randomized, Parallel Assignment, Efficacy Study NCT01004458

CBT; Waiting list Fibromyalgia Comp 48 Adt

F-only

Jan-01 Dec-08 Uppsala University http://ClinicalTrials.gov/show/NCT01004458








102

Effectiveness of Dance on Patients With Fibromyalgia Randomized, Parallel Assignment, Efficacy Study NCT00961805

Dance Fibromyalgia Comp 80 Adt

F-only

Aug-07 Nov-08 Federal University of Sao Paulo


HRV Biofeedback in Fibromyalgia RCT (placebo), Efficacy Study NCT00222274

RSA Biofeedback; EEG Biofeedback Condition


Active, NR

80 Adt

F-only

Jul-04 Sep-08 University of Medicine and Dentistry New Jersey; Arthritis Foundation


The effect of education about pain on illness perceptions in patients with fibromyalgia: a randomised clinical trial with a six-month follow up RCT ISRCTN86684957

Information on pain & sensitisation; Information on possible effects of relaxation exercises and how to perform them. Both groups received follow up phone calls.

Fibromyalgia Comp 200 Adt Oct-08 Jun-08 University of Antwerp


Web-Based Education to Enhance Fibromyalgia Management RCT (active), Efficacy Study NCT00423631

Cognitive-behavioral therapy

Fibromyalgia; Fibrositis

Active, NR

170 Adt Sen

Sep-06 Jun-08 University of Michigan


Testing Mestinon and Exercise in Fibromyalgia Phase II: RCT (placebo) NCT00535587

Exercise + Pyridostigmine; Pyridostigmine + Placebo; Exercise + Attention control; Attention control + Placebo

Fibromyalgia Comp 178 Adt Sep-02 Jun-08 National Institute of Nursing Research (NINR)


Health Promotion for Women With Fibromyalgia Randomized, Parallel Assignment, Efficacy Study NCT00596674

Lifestyle Counts; Attention Control


177 Adt Sen

F-

only

Jul-03 May-08

University of Texas at Austin; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)









103

Device

Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM) Randomized, Crossover Assignment NCT00932360

Transient Placebo TENS (Rehabilicare Maxima TENS); Active TENS (Rehabilicare Maxima TENS); No TENS


Jun-09 Jun-12 University of Iowa; Orthopedic Section of the American Physical Therapy Association


Study of Mattress Type in Fibromyalgia Phase II: Randomized, Crossover Assignment, Efficacy Study NCT01108718

Brand name mattress; Comparison mattress


F-

only

Jul-09 Oct-10 Beth Israel Medical Center


The efficacy of cranial electrotherapy stimulation for the reduction of pain in fibromyalgia RCT (placebo) ACTRN12609000711213

Cranial electrotherapy; Sham therapy

Fibromyalgia Active 30 Adt Sen

Aug-08 > Sep-09

Pacific Medistim, Queensland


Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain Phase II: RCT (placebo), Safety/Efficacy Study NCT00524420

rTMS; Sham rTMS Fibromyalgia; Chronic Pain; Depression

Rec 44 Adt

F-only

Feb-08 Sep-10 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); University of Washington


Vagus Nerve Stimulation for Treating Adults With Severe Fibromyalgia Phase I: Single Group Assignment, Safety/Efficacy Study NCT00294281

Vagus Nerve Stimulation (VNS) Therapy


40 Adt Oct-06 Jun-10 National Institute of Arthritis and Musculoskeletal and Skin Diseases


Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia Phase I/II: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00928720

Cranial electrical stimulation (CES) device (Alpha-Stim); sham device


Jun-09 May-10

University of Virginia









104

Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain Disorders Phase III: RCT (placebo), Efficacy Study NCT00374673

Repetitive transcranial magnetic stimulation

Fibromyalgia; Irritable Bowel Syndrome; Burning Mouth Syndrome

Rec 90 Adt Sen

Oct-06 Jan-10 Hôpital Ambroise Paré


Occipital Transcranial Direct Current Stimulation in Fibromyalgia Phase I/II: RCT (placebo), Safety/Efficacy Study NCT00947622

Transcranial direct current stimulation

Fibromyalgia Rec 35 Adt

F-only

Jul-09 Nov-09 University Hospital, Antwerp


Occipital Nerve Stimulation in Fibromyalgia Phase II: Crossover Assignment (placebo) NCT00917176

Occipital nerve stimulation

Fibromyalgia Comp Adt

F-only

NK ? Jun-09

University Hospital, Antwerp


Pain Relief Investigation of Neuromodulation Therapy in an Adult Fibromyalgia Population Phase III: RCT (placebo), Safety/Efficacy Study NCT00450905

PRIMA Device Fibromyalgia; Pain

Term 200 Adt Sen

Mar-07 Dec-08 Fralex Therapeutics; PharmaNet; McDougall Scientific Limited


Dietary Supplement

Treatment of Chronic Fatigue Syndrome and Fibromyalgia With D-ribose: a Multicenter Study Single Group Assignment, Safety/Efficacy Study NCT01108549

Ribose Fibromyalgia; Chronic Fatigue Syndrome

Comp 257 Adt Sen

Apr-09 Sep-09 Kona Research Center; Bioenergy Life Science, Inc.; Integrative Therapeutics Inc


The Role of Ribose in Patients Diagnosed With Fibromyalgia Randomized, Parallel Assignment NCT00566514

D-ribose; dextrose Fibromyalgia Susp 200 Adt Sen

Jul-06 Jul-08 Bioenergy Life Science, Inc.








105


Pregabalin In Adolescent Patients With Fibromyalgia Phase IV: Single Group Assignment, Safety Study NCT01020526

Pregabalin Fibromyalgia Not yet Rec

162 Child Adt

Jul-10 Jul-13 Pfizer http://ClinicalTrials.gov/show/NCT01020526

Pediatric Fibromyalgia Study Phase IV: Randomized, Parallel Assignment, Safety/Efficacy Study NCT01020474

Pregabalin, Placebo

Fibromyalgia Not yet Rec

162 Child Apr-10 Jan-13 Pfizer http://ClinicalTrials.gov/show/NCT01020474

Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome Phase II/III: RCT (placebo), Safety/Efficacy Study NCT00375973

Duloxetine Fatigue Syndrome, Chronic

Rec 60 Adt Sep-06 Dec-11 University of Cincinnati; Eli Lilly and Company


A Study for Adult Patients With Fibromyalgia Phase IV: RCT (placebo), Safety/Efficacy Study NCT00965081

Duloxetine; Placebo Fibromyalgia, Primary; Fibromyalgia, Secondary

Rec 308 Adt Sen

Sep-09 Aug-11 Eli Lilly and Company


Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia Phase III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00830167

Pregabalin; Placebo


Mar-09 Jul-11 Pfizer http://ClinicalTrials.gov/show/NCT00830167

An fMRI Study Of Brain Response In Patients With Fibromyalgia Phase I: Randomized, Crossover Assignment, Pharmacodynamics Study NCT00760474

Pregabalin, then placebo; Placebo, then pregabalin


F-

only

Jan-09 Jun-11 Pfizer http://ClinicalTrials.gov/show/NCT00760474

Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia Phase IV: Randomized, Parallel Assignment, Safety/Efficacy Study NCT01077375

Milnacipran; Placebo


Feb-10 Mar-11 Forest Laboratories; Cypress Bioscience, Inc.









106

Fibromyalgia Health Outcome Study on Cost of Treatments Observational: Prospective Cohort Study NCT00725101

Treatment for Fibromyalgia


Jun-08 Mar-11 Eli Lilly and Company


A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia Phase III: Single Group Assignment, Safety Study NCT00830128

Pregabalin Fibromyalgia Rec 250 Adt Sen

Jul-09 Feb-11 Pfizer http://ClinicalTrials.gov/show/NCT00830128

A Study for Adolescents With Fibromyalgia Syndrome Phase IV: Single Group Assignment NCT01089621

Duloxetine Fibromyalgia Rec 20 Child Mar-10 Jan-11 Eli Lilly and Company


Cyclobenzaprine Extended Release (ER) for Fibromyalgia Phase IV: RCT (placebo), Efficacy Study NCT01041495

Cyclobenzaprine ER (AMRIX); placebo

Fibromyalgia; Pain; Sleep; Fatigue

Rec 60 Adt Jun-09 Dec-10 State University of New York - Upstate Medical University; Cephalon


Pilot study to investigate the endocrinological, physiological and pain reducing effects of gamma hydroxybutyric acid in combination with operant behaviour pain therapy on patients with FibroMyalgia Syndrome RCT (placebo) ISRCTN01680675

Gamma hydroxybutyric acid alongside operant behaviour therapy; placebo


Oct-06 Dec-10 Charite – University Medicine Berlin


Neurotropin to Treat Fibromyalgia Phase II: RCT (placebo), Safety/Efficacy Study NCT00366535

Neurotropin Fibromyalgia Rec 36 Adt Sen

F-

only

Aug-06 Dec-10 National Institute of Nursing Research (NINR)









107

Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia Phase III: Single Group Assignment, Safety Study NCT00803023

Sodium Oxybate; Sodium Oxybate & Tablet; Sodium Oxybate Oral Solution (6 grams)


Mar-10 Dec-10 Jazz Pharmaceuticals


Study of T3 for the Treatment of Fibromyalgia Non-Randomized, Crossover Assignment, Efficacy Study NCT00903877

T3 Fibromyalgia Rec 20 Adt May-09

Dec-10 Stanford University http://ClinicalTrials.gov/show/NCT00903877

Maintenance of Efficacy. Phase III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00796601

Esreboxetine; Placebo

Fibromyalgia Wtdwn 650 Adt Sen

May-09

Nov-10 Pfizer http://ClinicalTrials.gov/show/NCT00796601

Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Phase III: Randomized, Crossover Assignment, Safety/Efficacy Study NCT00933686

Somatropine; Placebo


123 Adt Sen

F-

only

Dec-07 Nov-10 EMD Serono http://ClinicalTrials.gov/show/NCT00933686

Study Assessing the Efficacy of Etoricoxib in Female Patients With Fibromyalgia Phase IV: RCT (placebo), Efficacy Study NCT00755521

Etoricoxib Fibromyalgia Not yet Rec

80 Adt Sen

F-

only

Sep-08 Oct-10 Meir Medical Center


Effect of Milnacipran in Patients With Fibromyalgia Phase II: RCT (placebo), Efficacy Study NCT01108731

Minalcipran; Placebo

Fibromyalgia Rec 45 Adt Mar-10 Aug-10 Beth Israel Medical Center; Forest Laboratories








108

Efficacy and safety of eslicarbazepine acetate as therapy in patients with fibromyalgia: A double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial RCT (placebo) UKCRN ID 6969 & NTR2167

Eslicarbazepine acetate


Apr-09 Aug-10 Bial Portela & Ca, S.A

http://public.ukcrn.org.uk/Search/ StudyDetail.aspx?StudyID=6969 http://www.trialregister.nl/trialreg/ admin/rctview.asp?TC=2167

Study of Indoleamine 2,3-dioxygenase Activity and Mirtazapine Efficacy in Fibromyalgia Syndrome Phase IV: RCT (placebo), Safety/Efficacy Study NCT00919295

Mirtazapine; placebo


Rec 216 Adt Sen

Dec-08 Aug-10 Mahidol University; University of Texas


Pharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in fibromyalgia RCT (active) NTR1343

Ketamine (I.V.); Midzolam (I.V.)

Fibromyalgia Active 24 N/K Feb-10 Jul-10 Leiden University Medical Center

http://www.trialregister.nl/trialreg/ admin/rctview.asp?TC=1343

Effects of Low Dose Naltrexone in Fibromyalgia Randomized, Crossover Assignment, Efficacy Study NCT00568555

Naltrexone Fibromyalgia; Persian Gulf Syndrome

Active, NR

60 Adt Jun-07 Jun-10 Stanford University; American Fibromyalgia Syndrome Association


Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia Phase IV: RCT (placebo), Efficacy Study NCT01014585

Milnacipran; Placebo


425 Child Adt Sen

Nov-09 Jun-10 Forest Laboratories; Cypress Bioscience, Inc.


Effects of Pregabalin (Lyrica) on Sleep Maintenance in Subjects With Fibromyalgia Phase III: Randomized, Crossover Assignment, Efficacy Study NCT00883740

Pregabalin; Placebo

Fibromyalgia; Sleep Disorders

Active, NR

100 Adt Sen

Jun-09 Jun-10 Pfizer http://ClinicalTrials.gov/show/NCT00883740

http://public.ukcrn.org.uk/Search/%20StudyDetail.aspx?StudyID=6969


http://www.trialregister.nl/trialreg/%20admin/rctview.asp?TC=2167








109

Fibromyalgia Treatment Trial With Gabapentin and Osteopathic Manipulative Medicine Phase III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT01107574

Gabapentin and Osteopathic Manipulative Medicine; Gabapentin; Osteopathic Manipulative Medicine

Fibromyalgia Comp 41 Adt Apr-04 Apr-10 Good Samaritan Regional Medical Center, Oregon


Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome Phase II: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00445705

AGN 203818; Placebo


650 Adt Sen

F-

only

Apr-07 Apr-10 Allergan http://ClinicalTrials.gov/show/NCT00445705

Comparative Efficacy and Tolerability of Quetiapine XR and Amitriptyline in the Treatment of Fibromyalgia Phase IV: RCT (active), Safety/Efficacy Study NCT00766350

Amitriptyline; quetiapine


Nov-08 Mar-10 Universidad de Granada; AstraZeneca; Hospital Clinico Universitario San Cecilio


Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia. Phase III: Single Group Assignment, Non-Randomized (active), Safety/Efficacy Study NCT00423605

Xyrem® Fibromyalgia Active, NR

561 Adt Sen

Dec-06 Mar-10 Jazz Pharmaceuticals


The effect of ketamine on inhibitory pain mechanimsm in the central nervous system in chronic pain patients. RCT (active) NTR2005

Ketamine (I.V.) Fibromyalgia; Complex Regional Pain Syndrome; Central neuropathic pain

N/K 60 Adt Sen

Jan-09 Jan-10 Leiden University Medical Center

http://www.trialregister.nl/trialreg/ admin/rctview.asp?TC=2005

Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia Phase III: RCT (active), Safety/Efficacy Study NCT00797797

Pregabalin; milnacipran


Nov-08 Jan-10 Forest Laboratories http://ClinicalTrials.gov/show/NCT00797797








110

Quetiapine (Seroquel XR) for the Treatment of Fibromyalgia: a Clinical and Mechanistic Pilot Study Phase IV: RCT (placebo), Efficacy Study NCT00983320

Quetiapine; placebo Fibromyalgia Rec 55 Adt

F-only

Apr-08 Jan-10 Universitaire de Sherbrooke; University of Montreal


An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue Phase IV: RCT (placebo), Safety/Efficacy Study NCT00678691

Armodafinil; placebo

Fibromyalgia, Primary

Rec 60 Adt Aug-07 Dec-09 State University of New York - Upstate Medical University


Quetiapine Compared With Placebo in the Management of Fibromyalgia RCT (placebo), Efficacy Study NCT00710918

Quetiapine; Placebo

Fibromyalgia Rec 42 Adt Jun-08 Dec-09 East Tennessee State University Research Foundation


Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia Phase III: RCT (placebo), Safety/Efficacy Study NCT00793520

Milnacipran, Placebo

Fibromyalgia Term 36 Adt Sen

Nov-08 Nov-09 Forest Laboratories http://ClinicalTrials.gov/show/NCT00793520

Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran Phase II: RCT (placebo), Safety/Efficacy Study NCT00757679

Milnacipran Fibromyalgia Syndrome

Rec 80 Adt Sen

F-

only

Sep-06 Oct-09 Pierre Fabre Medicament


Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia Phase IV: Single Group Assignment, Safety/Efficacy Study NCT00791739

Trazodone, Pregabalin


Apr-08 Oct-09 Universidad de Granada








111

A Study of Quetiapine Fumarate Sustained Release in Major Depression With Comorbid Fibromyalgia Syndrome Phase IV: RCT (placebo), Safety/Efficacy Study NCT00675896

Quetiapine Fumarate Sustained Release; Placebo

Major Depression, Fibromyalgia

Rec 120 Adt Apr-07 Sep-09 Dr Alexander McIntyre Inc.


Calcitonin in the Treatment of Fibromyalgia Phase IV: Randomized, Crossover Assignment, Safety/Efficacy Study NCT00754884

Salmon calcitonin; intranasal saline solution plus glycerol

Fibromyalgia Invite 40 Adt

F-only

Oct-08 Aug-09 Unidad de Investigacion en Enfermedades Cronico-Degenerativas


A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia Phase IV: RCT (placebo), Safety/Efficacy Study NCT00673452

Duloxetine hydrochloride; placebo


Jun-08 Jul-09 Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals


Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers Phase I: Randomized, Crossover Assignment, Safety Study NCT00809289

Esreboxetine; Placebo; Moxifloxacin

Fibromyalgia Comp 40 Adt Dec-08 Jul-09 Pfizer http://ClinicalTrials.gov/show/NCT00809289

Open Label Extension Study of [S,S]-Reboxetine in Patients With Fibromyalgia Phase III: Single Group Assignment, Safety/Efficacy Study NCT00754221

[S,S]-Reboxetine Fibromyalgia Term 800 Adt Sen

May-08

Jun-09 Pfizer http://ClinicalTrials.gov/show/NCT00754221

Long-Term OL Study of [S,S]-RBX in Patients With Fibromyalgia Phase III: Single Group Assignment, Safety Study NCT00607256

[S,S]-Reboxetine Fibromyalgia Term 500 Adt Sen

Nov-07 Jun-09 Pfizer http://ClinicalTrials.gov/show/NCT00607256

Armodafinil for Fibromyalgia Fatigue Phase III: RCT (placebo), Efficacy Study NCT00568919

Armodafinil; Placebo

Fibromyalgia; Fatigue

Comp 60 Adt Sep-07 Jun-09 State University of New York - Upstate Medical University; Martin Morell MD Arthritis Associates









112

A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia. Phase II: Randomized, Crossover Assignment, Safety/Efficacy Study NCT00752505

Esreboxetine Fibromyalgia Comp 89 Adt Aug-08 Jun-09 Pfizer http://ClinicalTrials.gov/show/NCT00752505

A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia. Phase III: RCT (placebo), Safety/Efficacy Study NCT00423813

Xyrem®; Placebo Fibromyalgia Comp 573 Adt Sen

Dec-06 Jun-09 Jazz Pharmaceuticals


A 14-Week, Multi-Center Study of [S,S]-Reboxetine in Patients With Fibromyalgia. Phase III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00612170

[S,S]-Reboxetine; Placebo


Dec-07 May-09

Pfizer http://ClinicalTrials.gov/show/NCT00612170

Multi-Centre Randomised Double Blind Placebo Controlled Clinical Trial of the Effect of Neurotec in Fibromyalgia Syndrome RCT (placebo) ACTRN12609000065291

Neurotec; Placebo Fibromyalgia syndrome

Comp N/K Adt Sen

Nov-08 > Mar-09

Iran Rheumatology Center

http://www.anzctr.org.au/ trial_view.aspx?ID=83304

This Open-label Study Will Evaluate the Analgesic Effectiveness and Safety Measurement of Tramadol HCl/Acetaminophen in the Treatment of Pain for Fibromyalgia. Phase IV: Single Group Assignment, Safety/Efficacy Study NCT00766675

Ultracet (tramadol HCL/acetaminophen)

Pain; Fibromyalgia

Comp 82 Adt Sen

May-08

Mar-09 Johnson & Johnson Taiwan Ltd


Eszopiclone in the Treatment of Insomnia and Fibromyalgia Phase IV: Randomized, Parallel Assignment, Efficacy Study NCT00392041

Eszopiclone; placebo

Fibromyalgia; Insomnia

Comp 95 Adt Aug-06 Mar-09 University of Medicine and Dentistry New Jersey; Sepracor, Inc.





http://www.anzctr.org.au/%20trial_view.aspx?ID=83304




113

A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia Phase II: Randomized, Parallel Assignment, Efficacy Study NCT00696787

Desvenlafaxine Sustained Release (DVS SR); Lyrica® (Pregabalin); Placebo

Fibromyalgia Term 125 Adt Sen

F-

only

Jun-08 Jan-09 Wyeth http://ClinicalTrials.gov/show/NCT00696787

A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia Phase III: RCT (placebo), Safety/Efficacy Study NCT00371137

Xyrem®; Placebo Fibromyalgia Comp 548 Adt Sen

Aug-06 Dec-08 Jazz Pharmaceuticals


Pramipexole ER vs. Placebo in Fibromyalgia Phase II: Parallel Assignment, Safety/Efficacy Study NCT00689052

Pramipexole ER Fibromyalgia Term 61 Adt Sen

Jul-08 Nov-08 Boehringer Ingelheim Pharmaceuticals


The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults. Phase II: RCT (placebo), Safety/Efficacy Study NCT00464737

Rotigotine; Placebo Fibromyalgia Syndrome

Comp 230 Adt Mar-07 Nov-08 UCB, Inc. http://ClinicalTrials.gov/show/NCT00464737

FMS European Long-Term Study Phase III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00757731

Milnacipran Fibromyalgia Syndrome

Active, NR

468 Adt Sen

Oct-06 Oct-08 Pierre Fabre Medicament


Lidocaine on Manifestations of Fibromyalgia Phase I: Randomized, Parallel Assignment NCT00991848

Lidocaine Fibromyalgia; Chronic Pain

Comp 30 Adt Jan-05 Sep-08 Federal University of Sao Paulo


Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial NCT00071708

Duloxetine Hydrochloride

Major Depressive Disorder; Fibromyalgia; Diabetic Peripheral Neuropathic Pain; Generalized Anxiety Disorder

No longer

available

Adt Sen

N/K ? Jul-08

Eli Lilly and Company









114

A Study Of Milnacipran In Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure Monitoring Phase III: RCT (placebo), Safety Study NCT00618956

Milnacipran hydrochloride; Placebo


Oct-07 Jul-08 Forest Laboratories; Cypress Bioscience, Inc.


Multi-Centre Randomised Double Blind Placebo Controlled Clinical Trial of the Effect of Neurotec in Fibromyalgia Syndrome Single Group Assignment, Efficacy Study ACTRN12608000071325

Neurotec Fibromyalgia syndrome

Comp 10 Adt Sen

Apr-08 > Jun-09

Iran Rheumatology Center


Efficacy of Dolasetron in Patients With Fibromyalgia Phase III: RCT (placebo), Safety/Efficacy Study NCT00820326

Dolasetron; Placebo


Mar-04 Jun-08 University Hospital, Limoges


Study of Milnacipran for the Treatment of Fibromyalgia Phase III: RCT (placebo), Safety/Efficacy Study NCT00314249

Milnacipran 100mg; Placebo


Apr-06 Jun-08 Forest Laboratories; Cypress Bioscience, Inc.


The use of a natural medicine, S-adenolsylmethionine (SAM-e) in the treatment of Fibromyalgia and Chronic Fatigue Syndrome RCT (placebo), Efficacy Study ACTRN12607000377437

S-adenolsylmethionine (SAM-e); placebo

Fibromyalgia Com 120 Adt Sen

Sep-07 > Apr-08

Deakin University; Nutrition Care Pharmaceuticals



Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET RCT (placebo), Efficacy Study NCT00697398

Transcranial stimulation

Fibromyalgia Rec 40 Adt Oct-08 Oct-11 Assistance Publique Hopitaux De Marseille










115



Fibromyalgia, Knee Pain, Osteoarthritis, Shoulder Pain and other conditions

9

Invite 728 Adt Sen

May-09

Dec-10 University of Missouri-Columbia; National Library of Medicine (NLM)


Fibromyalgia Acupuncture Study RCT (placebo), Safety/Efficacy Study NCT00882271

Acupuncture Fibromyalgia Active, NR

50 Adt Sen

Jan-08 Aug-10 Southern California University of Health Sciences


Qigong For Treatment Of Fibromyalgia Single Group Assignment NCT00938834

CFQ Qigong Fibromyalgia Pain Not yet Rec

100 Adt Sen

Aug-09 Aug-10 Capital District Health Authority, Canada


Developing Biomarkers for Fibromyalgia RCT (placebo) NCT00932061

Traditional Acupuncture; Sham Treatment


Jun-08 May-10

University of Michigan; The Dana Foundation; Department of Defense


Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain RCT (placebo), Efficacy Study NCT00554320

tDCS; Chronic Pelvic Pain; Interstitial Cystitis; Post Traumatic Stress Disorder; Fibromyalgia; Irritable Bowel Syndrome

Comp 24 Adt

F-only

Jan-09 Jun-09 Summa Health System


A Study to Compare Two Ways of Completing Pain and Sleep Questions and to Evaluate a New Daily Questionaire for Assessing Fatigue in Fibromyalgia Patients Randomized, Crossover Assignment NCT00819624

Interactive Voice Response System (IVRS); Personal Digital Assisstant (PDA)


Jan-09 Mar-09 Pfizer http://ClinicalTrials.gov/show/NCT00819624

9 Acne Vulgaris; Allergic Rhinitis; Anxiety; Asthma; Back Pain; Prostatic Hyperplasia; Bursitis; Chronic Obstructive Pulmonary Disease; Cough; Coronary Artery Disease; Depression; Diabetes

Mellitus; Diarrhea; Gastroesophageal Reflux; Headache; HIV Infections; Hypothyroidism; Hyperlipidemia; Hypertension; Influenza; Sleep Initiation and Maintenance Disorders; Irritable Bowel Syndrome; Migraine Disorders; Obesity; Obstructive Sleep Apnea; Senile Osteoporosis; Colonoscopy; Mammography; Sinusitis; Smoking Cessation; Tobacco Use Cessation; Menopause; Urinary Incontinence; Urinary Tract Infection; Vaccination; Vaginitis; Vertigo







116

Multiple Symptoms Study: a feasibility study of a GP with special interest clinic for patients with multiple medically unexplained symptoms (MMUS) RCT ISRCTN63083469

Symptoms Clinic; Usual care

Medically unexplained disorders including fibromyalgia

Comp 120 Adt Oct-09 Apr-10 University of Edinburgh


Benefits of Tanning in Fibromyalgia Patients Single Group Assignment, Efficacy Study NCT00447083

Ultraviolet Light Fibromyalgia Syndrome

Comp 19 Adt May-05

Sep-08 Wake Forest University


Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia Phase I/ II: Randomized, Parallel Assignment, Efficacy Study NCT00142597

Acupuncture Fibromyalgia Comp 80 Adt Sen

F-

only

May-05

May-08

University of Michigan; National Center for Complementary and Alternative Medicine (NCCAM)



Evaluation and Diagnosis of People With Pain and Fatigue Syndromes Observational: Prospective NCT00677157

Fatigue; Fibromyalgia;

Pain; Complex Regional Pain Syndrome; Reflex Sympathetic Dystrophy

Rec 1000 Adt Sen

May-08

N/K National Institute of Nursing Research (NINR)


Observational Study of Control Participants for the MAPP Research Network Observational: Prospective Cohort Study NCT01098292

Fibromyalgia; Irritable Bowel Syndrome; Fatigue Syndrome, Chronic

Rec 630 Adt Sen

Dec-09 Dec-12 University of Pennsylvania; National Institute of Diabetes and Digestive and Kidney Diseases; University of Colorado, Denver








117

Web-Based Survey of Pain, Stress and Complementary and Alternative Medicine Observational: Prospective, Cohort Study NCT00740233

Gastrointestinal Diseases; Chronic Pain; Stress; Anxiety; Depression including fibromyalgia

Rec 1000 Adt Jun-08 Dec-10 University of California, Los Angeles; National Center for Complementary and Alternative Medicine


Fibromyalgia Rehabilitation - Access and Classification of Subgroups Observational: Cross-sectional Study DRKS00000300


Jan-10 > Oct-10

Universitäts-klinikum Friekburg Abteilung Qualitätsmanagment und Sozialmedizin

http://drks-neu.uniklinik-freiburg.de/drks_web/ navigate.do?navigationId= trial.HTML&TRIAL_ID=DRKS00000300

Cognitive and Memory Function in Patients With Fibromyalgia Observational: Prospective, Cohort Study NCT00789178

Fibromyalgia; Cognitive Impairment

Not yet Rec

80 Adt Sen

Dec-08 Apr-10 Assaf-Harofeh Medical Center


Association Between Hypermobility and Chronic Musculoskeletal Pain Observational: Cross-sectional, Case-control Study NCT01032863

Hypermobility, Joint; Arthralgia; Myofascial Pain Syndromes; Fibromyalgia; Pain Disorder

Comp 112 Adt Dec-09 Mar-10 Amrita Institute of Medical Sciences & Research Center


Distraction from pain in Fibromyalgia, Arthritis and healthy volunteers Observational UKCRN ID 4779

Fibromyalgia; Pain; Arthritis

Active 48 N/K N/K Dec-09 N/K http://public.ukcrn.org.uk/Search/ StudyDetail.aspx?StudyID=4779

Determining How the Nervous System Processes Pain in Adults With Fibromyalgia Observational: Cross-sectional, Case-control Study NCT00496886

Fibromyalgia; Rheumatoid Arthritis

Active, NR

120 Adt

F-only

Apr-06 ? May-09



Genetics of Fibromyalgia Observational: Retrospective, Family-Based Study NCT00071162

Fibromyalgia; Irritable Bowel Syndrome; Chronic Fatigue Syndrome; Depression

Active, NR

560 Child Adt Sen

Sep-99 ? Mar-09




http://drks-neu.uniklinik-freiburg.de/drks_web/%20navigate.do?navigationId=%20trial.HTML&TRIAL_ID=DRKS00000300










118

The Expectancy of Pain in Fibromyalgia, Osteoarthritis and Healthy Volunteers Observational UKCRN ID 4784

Fibromyalgia; OA Active 48 N/K N/K Dec-08 N/K http://public.ukcrn.org.uk/Search/ StudyDetail.aspx?StudyID=4784

A10: CHRONIC PAIN



Start Date

End Date

Sponsors URL


Pain Catastrophizing as a Cause for Systemic Inflammation Observational: Prospective, Case Control Study NCT00823147

Pain Catastrophizing Induction

Chronic MSK Pain

Rec 60 Adt

F-only

Jan-09 Jun-20 Oregon Health and Science Uni.; Oregon Clinical and Translational Research Institute; Office of Research on Women's Health (ORWH)


Chronic Pain and Opioid Dependence Assessment and Treatment Single Group Assignment, Efficacy Study NCT00727675

Integrated Cognitive Behavioral Therapy

Chronic Pain; Opioid Dependency

Rec 20 Adt Aug-08 Jul-15 Yale Uni.; National Institute on Drug Abuse (NIDA)


Clinical Trial of Integrated Treatment for Pain and Opioid Dependence Phase I/II: Randomized, Factorial Assignment, Efficacy Study NCT00634803

CBT; Educational Counseling; Drug: Buprenorphine

Opiate Dependence; Chronic Pain

Rec 76 Adt Sep-09 Aug-14 Yale Uni. http://ClinicalTrials.gov/show/NCT00634803

Telehealth Therapy for Chronic Pain Randomized, Paralled, Efficacy Study NCT01055639

In-Person Acceptance and Commitment Therapy; Telehealth Acceptance and Commitment Therapy

Chronic Pain Not yet Rec

196 Adt Sen

Feb-10 Sep-13 Department of Veterans Affairs








119

Pain and Substance Use Disorders Randomized, Efficacy Study NCT00982410

CBT; Educational supportive group


128 Adt Sen

Apr-10 Apr-13 Department of Veterans Affairs


Telephone Intervention for Pain Study (TIPS) Randomized, Parallel Assignment, Efficacy Study NCT00663663

Telephone-Delivered CBT; Telephone Delivered Education Intervention

Chronic Pain; Multiple Sclerosis; Amputation; Spinal Cord Injuries

Invite 160 Adt Sen

Sep-09 Dec-12 Uni. of Washington http://ClinicalTrials.gov/show/NCT00663663

Contextual Cognitive-Behavioural Therapy (CBT) for the Self-Management of Chronic Pain in the Community: A Feasibility Study Observational UKCRN ID 8111

Contextual CBT Chronic pain Not yet Rec

116 Adt Sen

N/K Mar-12 Bath Royal National Hospital for Rheumatic Diseases


Effectiveness of a Training Program in Improving Coping Skills in People With Arthritis Pain Phase II/III: Randomized, Parallel Assignment, Efficacy Study NCT00636454

Coping skills training (CST) for chronic pain; Usual care

OA Rec 272 Adt Sen

May-08

Jan-12 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Training to improve analgesic prescription for chronic pain Non-randomized, controlled trial ISRCTN93882803

GP training in psychological flexibility; control

GPs treating patients with Chronic pain

Active 196 Adt Sen

Sep-09 Oct-11 University of Bath http://www.controlled-trials.com/ISRCTN93882803

Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain Randomized, Parallel Assignment, Efficacy Study NCT01091090

CBT; Control Smoking Cessation

Rec 60 Adt Sen

Nov-09 Apr-11 Mayo Clinic http://ClinicalTrials.gov/show/NCT01091090

Prerecorded Autosuggestion in Long-standing Pain Intervention RCT (active), Efficacy Study NCT01039727

Care as usual + 5 specific CDs; Care as usual + email assistance + AoL + CDs

Pain Not yet Rec

100 Adt Sen

Dec-09 Dec-10 Free Uni. Medical Center


Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain RCT (active), Efficacy Study NCT00371267

CBT; Pain Education

Pain Active, NR

101 Adt Sen

Oct-06 Oct-10 Department of Veterans Affairs












120

Cognitive Behavioral Therapy, Self-Efficacy, and Depression in Persons With Chronic Pain Retrospective NCT01055665

CBT Depression; Chronic Pain

Invite 138 Adt Sen

Oct-09 Sep-10 Mayo Clinic http://ClinicalTrials.gov/show/NCT01055665

Managing Unexplained Symptoms (chronic widespread pain) In primary Care: Involving traditional and Accessible New approaches RCT ISRCTN67013851

Telephone based CBT; prescribed exercise; telephone based CBT + exercise; Treatment as usual

Chronic Widespread Pain

Active 552 Adt Sen

Oct-07 Sep-10 University of Aberdeen


Treatment Of Chronic Pain Using Real Time fMRI Phase II: RCT (placebo), Safety/Efficacy Study NCT00528346

Cognitive training using fMRI; Placebo

Chronic Pain Rec 144 Adt Sep-07 Aug-10 Omneuron; National Institute of Neurological Disorders and Stroke (NINDS)


Evaluating a Chronic Pain Treatment Program Phase I: Single Group Assignment, Efficacy Study NCT00861302

Mind-body emotional awareness program

Chronic MSK Pain

Rec 100 Adt Sen

Sep-08 Aug-10 Wayne State Uni.; Blue Cross Blue Shield


Improving Chronic Pain Treatment in Primary Care RCT (active), Efficacy Study NCT00129480

Assistance with Pain treatment

Pain; Chronic Disease; Depression

Active, NR

401 Adt Sen

Jan-06 Jul-10 Department of Veterans Affairs


A Telephone Feedback System for Prevention of Chronic Pain Relapse Phase II: RCT (active), Efficacy Study NCT00266773

Chronic pain therapeutic interactive voice response (TIVR) system

Chronic Pain and Relapse Prevention

Rec 150 Adt Sen

Nov-05 Jul-10 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Uni. of Vermont; Fletcher Allen Health Care


Using Functional MRI to Evaluate Cognitive Behavioral Therapy Treatment Response in Adults With Chronic Pain Phase I/II: RCT (active), Efficacy Study NCT00796536

Group CBT; Pain education


40 Adt Sen

Jun-09 Jun-10 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)










121

Impact of a Course on Stress Reduction Single Group Assignment, Efficacy Study NCT00902863

Yoga Chronic Pain Terminated

5 Adt Sen

Feb-09 Mar-10 Hamilton Health Sciences


Behavioral Treatments for Chronic Pain RCT (active), Efficacy Study NCT00371865

CBT; Acceptance-based therapy

Intractable Pain Comp 114 Adt Sen



Piloting IVR (Interactive Voice Response) for Chronic Pain Treatment Single Group Assignment, Efficacy Study NCT00651924

IVR-based CBT Chronic Pain Comp 4 Adt Sen

Dec-08 Apr-09 Department of Veterans Affairs


I Am Able: Population Based Rehabilitation in a Family Health Team Non-randomized, Parallel Assignment, Efficacy Study NCT00859638

Physiotherapy; Occupational Therapy; Capacity Building

Chronic Conditions; Arthritis; Diabetes; Hypertension; Chronic Pain

Active, NR

119 Adt Sen

May-08

Apr-09 Hamilton Health Sciences; Ontario Neurotrauma Foundation


Effect of Music Therapy on Pain RCT (active), Efficacy Study NCT01020032

Individual receptive music therapy by “U sequence" method"

Chronic Pain Comp 87 Adt Sen

Sep-06 Dec-08 Association de Musicothérapie Applications et Recherches Cliniques


Treatment of Insomnia Secondary to Chronic Pain RCT (active), Efficacy Study NCT00127790

CBT for Insomnia and/or Pain

Insomnia; Pain Active, NR

44 Adt Sen

Jun-05 Nov-08 Uni. of Rochester; National Institute of Neurological Disorders and Stroke; National Institute on Aging; National Institutes of Health


Cognitive group therapy in the treatment of catastrophizing in patients with chronic non-cancer pain. Cohort Study NTR1157

Cognitive Group therapy

MSK pain Comp 6 Adt Jan-08 Oct-08 University Hospital Maastricht










122

Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients Phase I: RCT (placebo) NCT00133601

CBT Insomnia; Chronic Pain

Comp 28 Adt Sen

Oct-04 Oct-08 National Institute of Nursing Research (NINR); National Institutes of Health (NIH)


Device

Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain Phase II: RCT (placebo), Safety/Efficacy Study NCT00524420

rTMS; Sham rTMS Fibromyalgia; Chronic Pain; Depression

Rec 44 Adt

F-only

Feb-08 Sep-10 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Uni. of Washington


External peripheral neuromodulation for the relief of chronic pain RCT ISRCTN07743794

External peripheral neuromodulation; Sham

Chronic pain Active 40 Adt Sen

Aug-09 Aug-10 Guy‟s and St Thomas‟ NHS Foundation Trust, UK


Does the Spinal Modulation Neurostimulator System provide safe and efficacious pain relief in people with chronic pain? Single Group Assignment ACTRN12609000739213

Spinal modulation Neurostimulator System

Chronic pain Comp 10 Adt Sen

Sep-09 > Sep-09

Five Corners Pty Ltd, Australia


Prometra Implantable Programmable Pump Single Group Assignment, Safety/Efficacy Study NCT00817596

Infusion Pump (Prometra)

Intractable Pain Active, NR

110 Adt Sen

Jan-07 Apr-09 InSet Technologies http://ClinicalTrials.gov/show/NCT00817596

Prometra's Utilization in Mitigating Pain II NCT00866164

Prometra Programmable Pump

Intractable Pain; Back Pain; Leg Pain; Arm Pain; Trunk Pain

Expand Adt Sen

N/K ? Mar-09

InSet Technologies http://ClinicalTrials.gov/show/NCT00866164

Autonomic Function Testing and Spinal Cord Stimulation in Chronic Visceral Pain Phase IV: Non-randomized (placebo) NCT00678717

Medtronic or ANS spinal cord stimulator; Sham

Chronic Pain Rec 60 Adt Feb-08 Feb-09 Vanderbilt Uni. http://ClinicalTrials.gov/show/NCT00678717










123

The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin RCT (placebo), Efficacy Study NCT00716326

TENS + exercise; Placebo TENS + exercise

Neuropathic Pain Comp 115 Adt Sen

Jan-07 Dec-08 Norwegian Fund for Postgraduate Training in Physiotherapy


SynchroMed II Post-Approval Study Phase IV: Observational: Prospective, Cohort Study NCT00773019

SynchroMed® II Programmable Drug Infusion Pump

Severe Spasticity; Chronic Pain

Comp 84 Adt Sen

Nov-04 Nov-08 MedtronicNeuro http://ClinicalTrials.gov/show/NCT00773019

Placebo Transcutaneous Electrical Nerve Stimulation (TENS) NCT00750321

Active TENS; Inactive Placebo; Transient Placebo

TENS Comp Adt N/K ? Sep-08

Uni. of Iowa http://ClinicalTrials.gov/show/NCT00750321


Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain Phase III: Single Group Assignment, Safety Study NCT01115569

Hydrocodone bitartrate


600 Adt Sen

May-10

Dec-11 Zogenix, Inc. http://ClinicalTrials.gov/show/NCT01115569

QTc and Perceived Sleep Follow up Among Chronic Pain Patients With Opiate Medication Single Group Assignment NCT00999440

Methadone Chronic Pain Not yet Rec

100 Adt Sen

Jan-10 Dec-11 Tel-Aviv Sourasky Medical Center


A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone Single Group Assignment, Safety Study NCT00945919

Oxymorphone ER Chronic Nociceptive Pain; Neuropathic Pain; Non-cancer Pain

Rec 12 Adt Sen

Jul-09 May-11 Mount Sinai School of Medicine; Endo Pharmaceuticals


Study to Evaluate the Efficacy of Dronabinol (Marinol) as Add-On Therapy for Patients on Opioids for Chronic Pain Phase II/III: RCT (placebo), Safety/Efficacy Study NCT00153192

Marinol (dronabinol) Chronic Pain Active, NR

30 Child Adt Sen

Apr-01 Apr-11 Brigham and Women's Hospital; Solvay Pharmaceuticals









124

Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug (NSAID) Treatment Phase III: Single Group Assignment, Safety Study NCT00984815

HZT-501 OA; RA; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain

Rec 100 Adt Sen

Sep-09 Mar-11 Horizon Therapeutics, Inc.


Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients Phase IV: Randomized, Crossover Assignment, Pharmacodynamics Study NCT01100437

EMBEDA™ (morphine sulfate/ naltrexone hydrochloride) whole; EMBEDA™ crushed

Chronic Pain Rec 80 Adt Sen

Apr-10 Dec-10 Alpharma Pharmaceuticals LLC, a subsidiary of King Pharmaceuticals, Inc.


A Long-Term Study of JNS020QD (Fentanyl) in Chronic Pain Patients Phase III: Single Group Assignment, Safety/Efficacy Study NCT00788372

Fentanyl Pain Active, NR

138 Adt Sen

Sep-08 Dec-10 Janssen Pharmaceutical K.K.


Effect of Ketamine on Opioid-Induced Hyperalgesia Randomized, Parallel Assignment, Efficacy Study NCT00833755

Ketamine Pain; Chronic Pain; Hyperalgesia

Rec 136 Adt Sep-08 Dec-10 Massachusetts General Hospital


Hormone Function in Men Treated for Pain With Opioids or Placebo Phase IV: RCT (placebo), Safety Study NCT00737737

MS Contin Chronic Pain; OA Rec 18 Adt

M-only

Aug-08 Dec-10 National Institute of Nursing Research (NINR)


Modulation of Central Hypersensitivity in Musculoskeletal Pain by Intravenous Tropisetron Phase II: Randomized, Crossover Assignment, Efficacy Study NCT00889499

Tropisetron 2mg; Tropisetron 5mg; Placebo

Pain; Chronic Disease

Not yet Rec

30 Adt Sen

Apr-09 Sep-10 Uni. Hospital Inselspital, Berne


A population study in patients who do not respond to oral codeine ISRCTN16874724

Oral Codeine Chronic pain Active 150 Adt Sen

Jan-09 Sep-10 Leeds Teaching Hospitals NHS Trust, UK










125

Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients Phase IV: RCT (active), Efficacy Study NCT00879996

Methadone; Buprenorphine/naloxone

Opiate Addiction Rec 60 Adt Sen

Feb-09 Aug-10 State Uni. of New York at Buffalo; National Institute on Alcohol Abuse and Alcoholism (NIAAA)


The Effect of Intravenous Lidocaine on Allodynia Single Group Assignment (dose comparison), Efficacy Study NCT00659633

Lidocaine Pain Rec 10 Adt Sen

Dec-08 Jul-10 Uni. of Alabama at Birmingham; American Society of Regional Anesthesia


A Safety and Effectiveness Study of Intraspinal MDT2004 for the Treatment of Chronic Pain Phase II: RCT (placebo), Safety/Efficacy Study NCT00414466

Intraspinal MDT2004

Chronic Intractable Pain

Active, NR

144 Adt Sen

Dec-06 Jun-10 MedtronicNeuro http://ClinicalTrials.gov/show/NCT00414466

A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers. Phase I: Non-randomized, Parallel Assignment, Pharmacokinetics Study NCT01119235

PF-04531083 Chronic Pain Not yet Rec

24 Adt May-10

Jun-10 Pfizer http://ClinicalTrials.gov/show/NCT01119235

Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic Phase III: Single Group Assignment, Safety/Efficacy Study NCT00983073

Tapentadol Chronic Pain; OA Rec 180 Adt Sen

Sep-09 Jun-10 Grünenthal GmbH http://ClinicalTrials.gov/show/NCT00983073






126

Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking WHO Step III Analgesics But Showing a Lack of Tolerability Phase III: Single Group Assignment, Safety/Efficacy Study NCT00982280

Tapentadol Chronic Pain; OA Rec 180 Adt Sen

Sep-09 Jun-10 Grünenthal GmbH http://ClinicalTrials.gov/show/NCT00982280

Effect of Extended-Release Oxymorphone Taking With or Without Food on Cognitive Functioning Phase IV: Randomized, Crossover Assignment, Pharmacodynamics Study NCT00930943

Oxymorphone ER (Opana ER)

Chronic Non-Malignant Pain

Rec 32 Adt May-09

May-10 MedVadis Research Corporation


To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications Phase I: Randomized, Parallel Assignemtn, Pharmacokinetics Study NCT01103739

PF-04531083; Simvastatin

Chronic Pain Rec 24 Adt Mar-10 Apr-10 Pfizer http://ClinicalTrials.gov/show/NCT01103739

Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected Phase I: Non-randomized, Parallel Assignment, Efficacy Study NCT01030640

Tanezumab; Placebo

OA Pain; Chronic Low Back Pain; Pain Due to Interstitial Cystitis

Active, NR

28 Adt Jan-10 Apr-10 Pfizer http://ClinicalTrials.gov/show/NCT01030640

The Preemptive Analgetic Potency of Low Dose S-Ketamine Phase III RCT (dose comparison), Safety/Efficacy Study NCT01022840

S-Ketamine; Placebo

Pain Rec 60 Adt Sen

Feb-09 Mar-10 Medical Uni. of Graz







127

Efficacy and Safety of Fentanyl Buccal Tablets Compared With Immediate Release Oxycodone for the Management of Breakthrough Pain in Opioid Tolerant Patients With Chronic Pain Phase III: RCT (active), Safety/Efficacy Study NCT00813488

Fentanyl Buccal Tablet; Immediate-Release Oxycodone


Dec-08 Jan-10 Cephalon http://ClinicalTrials.gov/show/NCT00813488

Effect of IV Lidocaine Infusions on Pain Single Group Assignment, Efficacy Study NCT00725504

Intravenous lidocaine

Pain Rec 100 Adt Sen

Sep-08 Dec-09 Stanford Uni. http://ClinicalTrials.gov/show/NCT00725504

Effects of opioid analgesics on driving ability of pain patients Non-randomized, Parallel Assignment, Efficacy Study DRKS00000262

Opioid analgesics Pain Comp 60 Adt Nov-09 > Nov-09

Bundesanstalt für Straβenwesen


A study to evaluate whether increased codeine levels are seen when both codeine and ketamine are given in small doses to well volunteers. Single Group Assignment, Pharmacokinetics Study ACTRN12610000283077

Ketamine + Codeine

Severe chronic pain

Comp 10 Adt Nov-09 > Nov-09

Flinders University, Australia


Randomized, Double-Blind Cross-Over Trial Of Buprenorphine and Low-Dose Naloxone Versus Buprenorphine Randomized, Crossover Assignment, Safety/Efficacy Study NCT00679458

Buprenorphine and low-dose naloxone; Buprenorphine alone

Pain, Chronic Comp 12 Adt Sen

Sep-08 Nov-09 University of California, Los Angeles; Reckitt Benckiser Pharmaceuticals, Inc


A Verification Study of a Long-term Use of JNS013 in Patients With Chronic Pain Phase III: Single Group Assignment, Safety/Efficacy Study NCT00736957

JNS013 Pain Comp 190 Adt Sen

Apr-08 Oct-09 Janssen Pharmaceutical K.K.











128

AZD2066 Cocktail Study Phase I Single Group Assignment, Bio-availability Study NCT00930306

AZD2066; Caffeine; Tolbutamide; Omeprazole Tablet, 20 mg; Midazolam Tablet, 7.5 mg

Chronic Pain Comp 15 Adt Jun-09 Sep-09 AstraZeneca http://ClinicalTrials.gov/show/NCT00930306

Sublingual Buprenorphine for Chronic Pain Phase II: Single Group Assignment, Efficacy Study NCT00612287

Buprenorphine Chronic Pain Not yet Rec

40 Adt Sen

Apr-09 Aug-09 National Institute on Drug Abuse (NIDA); Beth Israel Medical Center


A Multiple Dose Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04457845 in Healthy Volunteers Phase I: Randomized, Parallel Assignment, Safety Study NCT00836082

PF-04457845, FAAH inhibitor

Acute Pain; Chronic Pain

Comp 41 Adt Feb-09 Jul-09 Pfizer http://ClinicalTrials.gov/show/NCT00836082

An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain Phase III: Single Group Assignment, Safety/Efficacy Study NCT00487435

CG5503 Pain; OA; Low Back Pain

Comp 1166 Adt Sen

Feb-07 Jun-09 Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Grünenthal GmbH


Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-Malignant Pain Phase IV: RCT (placebo), Efficacy Study NCT00547885

Dihydrocodeine Pain Rec 60 Adt Sen

Oct-07 ? May-09

Norwegian Uni. of Science and Technology


A Double-Blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic OA Pain Phase III: RCT (placebo), Safety/Efficacy Study NCT00631319

OROS Hydromorphone

Chronic Pain Active, NR

400 Adt Sen

Feb-08 Apr-09 Neuromed Pharmaceuticals








129

Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain Phase III: RCT (active) NCT00463047

Fentanyl Buccal Tablets; Immediate-Release Oxycodone


Jun-07 Feb-09 Cephalon http://ClinicalTrials.gov/show/NCT00463047

A Confirmatory Study of JNS013 in Patients With Chronic Pain Phase III: Randomized, Parallel Assignment, Efficacy Study NCT00736853

Tramadol Hydrochloride + Acetaminophen; Tramadol Hydrochloride + Acetaminophen


May-08

Jan-09 Janssen Pharmaceutical K.K.


Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza Phase IV: Single Group Assignment, Safety/Efficacy Study NCT00640042

Morphine sulfate extended release capsules


Mar-08 Dec-08 King Pharmaceuticals


Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386 Phase I: Randomized, Parallel Assignment, Safety Study NCT00690079

AZD1386; Placebo Chronic Pain Comp 69 Adt Sen

Feb-08 Nov-08 AstraZeneca http://ClinicalTrials.gov/show/NCT00690079

Buprenorphine as a Treatment in Opiate Dependent Pain Patients Phase IV: RCT (active), Efficacy Study NCT00552578

Buprenorphine/ Naloxone

Opiate Addiction; Refractory Pain

Term 12 Adt Sen

Oct-07 Oct-08 State Uni. of New York at Buffalo


Double-Blind Follow-on Safety Study of HZT-501 in Subjects Who Have Completed Participation in HZ-CA-301 or HZ-CA-303 Phase III: RCT (active), Safety Study NCT00613106

Ibuprofen/ Famotidine; ibuprofen

OA; RA; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain

Comp 300 Adt Sen

Sep-07 Oct-08 Horizon Therapeutics, Inc.








130

AZD1386 Japanese Multiple Ascending Dosing Study Phase I: Randomized, Parallel Assignment, Safety Study|Primary Purpose: Treatment NCT00736658

AZD1386; Placebo Chronic Pain Comp 32 Adt Sen

Jun-08 Sep-08 AstraZeneca http://ClinicalTrials.gov/show/NCT00736658

A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation) Single Group Assignment NCT00580294

Oxymorphone IV Pain Comp 12 Adt Sen

Nov-07 Aug-08 Mount Sinai School of Medicine; Endo Pharmaceuticals


Study of D-Methadone in Patients With Chronic Pain Phase I/II: Randomized, Crossover Assignment, Safety/Efficacy Study NCT00588640

D-Methadone; Placebo

Pain including pain associated with

10

Comp 64 Adt Sen

Oct-04 Jul-08 Memorial Sloan-Kettering Cancer Center


A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain Phase III: Randomized, Parallel Assignment, Safety Study NCT00361504

Tapentadol (CG5503) PR; Oxycodone CR;

OA, Hip; OA, Knee; Lower Back Pain; Pain

Comp 1122 Adt Sen

Oct-06 Jul-08 Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; GrÃ¼nenthal GmbH


Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-Malignant, Chronic Pain Phase II: RCT (dose comparison), Safety Study NCT00485225

Transdermal patch (EN3270)

Chronic, Non Malignant Pain

Comp 77 Adt Jun-07 Jul-08 Endo Pharmaceuticals


Efficacy of Matrifen in Patients Older Than 18 Years With Severe, Chronic Pain Observational: Prospective, Case-only Study NCT00556270

Matrifen Severe, Chronic Pain

Comp 3000 Adt Sen

Nov-07 May-08 Nycomed http://ClinicalTrials.gov/show/NCT00556270

10 Bladder Cancer; Breast Cancer; CNS Cancer; Colon Cancer; Esophageal Cancer; Pancreatic Cancer; Prostate Cancer; Uterine Cancer; Head and Neck Cancer; Eye Cancer; Otorhinolaryngologic Neoplasms







131

Paracetamol and Glutathion Phase I: Single Group Assignment, Pharmacodynamics Study NCT01116596

Paracetamol Chronic Pain; Elderly

Comp 18 Sen Feb-07 May-08 Uni. Hospital, Clermont-Ferrand


Other including CAM

Stepped Care to Optimize Pain Care Effectiveness Phase III: Randomized, Efficacy Study NCT00926588

Stepped Care to Optimize Pain Care Effectiveness

Pain Rec 250 Adt Oct-09 Sep-13 Department of Veterans Affairs


Collaborative care: integrated antidepressant and psychotherapeutic treatment of concomitant pain and depressive disorder in primary care. RCT (active) NTR1089

Combined care (integrated antidepressant + psycho-therapeutic care)

Pain; Depression Active 219 N/K Sep-07 Feb-13 Trimbos-institute http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1089

Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST) RCT (placebo), Efficacy Study NCT01094782

Acupuncture; Sham Acupuncture; Neither

Pain Rec 150 Adt Jan-10 Dec-11 Massachusetts General Hospital; National Institutes of Health (NIH)


Study of practice pharmacist-led management of long-term pain RCT ISRCTN06131530

Pharmacist review; Pharmacist prescribing; Standard GP care

Chronic Pain Active 232 Adt Sen

Jan-10 Nov-10 University of Aberdeen


Integrative Medicine Consultation for Patients With Pain or Fatigue Randomized, Parallel Assignment NCT01058265

Integrative; Standard

Pain; Fatigue Rec 50 Adt Sen

Oct-09 Oct-10 Mayo Clinic http://ClinicalTrials.gov/show/NCT01058265

The Application of Performance Improvement Principles to the Patient Throughput Process in an Adult Outpatient Pain Treatment Clinic Observational: Prospective, Case-only Study NCT00888420

Performance Improvement Measures


Feb-08 Jul-10 Uni. of Alabama at Birmingham











132

Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients Retrospective NCT01052155

Urine Drug Testing Chronic Pain Invite 1000 Adt Sen

Feb-10 Jun-10 Pain Management Center of Paducah


Effect of electroacupuncture on opioid consumption by patients with chronic pain RCT (placebo), Efficacy Study ACTRN12609000676213

Electro-acupuncture

Chronic pain Comp 315 Adt Sen

Jul-09 > Oct-09

National Ageing Research Institute; Caulfield Pain Management and Research Centre; Royal Melbourne Hospital


Chronic Pain Care Network Single Group Assignment NCT00909493

Network Access Chronic Pain Active, NR

20 Adt Sen

Jun-08 May-09 Capital District Health Authority, Canada; Canadian Anesthesiologists' Society


Acceptability of an Acupuncture Intervention in Painful Elderly Single Group Assignment NCT01043692

Acupuncture Chronic Pain Comp 60 Adt Sen

Oct-07 Dec-08 Assistance Publique - Hôpitaux de Paris; Fondation de France


Is triage an effective way of initiating early intervention for patients with a chronic musuloskeletal condition on a hospital waiting list? RCT (active), Efficacy Study ACTRN12608000316303

Physiotherapy intervention; Waiting list

Chronic MSK pain


Jun-08 > Jun-08

University of Canberra



Evaluation of Pain Location, Pain Quality and Pain Patterns in Subjects With Chronic Pain Prospective, Cross-sectional Study NCT00284245

Pain; Chronic Disease

Rec 10000

Adt Sen

Jun-04 ? Taylor MicroTechnology


Observatory on Elderly Patients “Les S.AGES" Prospective, Cohort Study NCT01065909

Diabetes Mellitus, Type 2; Chronic Pain; Atrial Fibrillation

Rec 5800 Adt Sen

Apr-09 Oct-13 Sanofi-Aventis http://ClinicalTrials.gov/show/NCT01065909










133

Endogenous pain control mechanisms in patients with chronic arthritic pain UKCRN ID 4786

Chronic arthritic pain

Active 240 N/K N/K Aug-11 Hope Hospital, Manchester


Pain Responses in Patients on Long-Term Opioid Therapy for Chronic Pain Cross-sectional, Case-Control NCT00656942

Chronic Pain Rec 164 Adt Jul-06 Dec-10 Massachusetts General Hospital


Use of Driving Tests to Evaluate Patient Performance on Oral Opioids Phase III: Cross-sectional, Case-Control NCT00659035


Apr-08 Dec-10 Rush Uni. Medical Center


Web-Based Survey of Pain, Stress and Complementary and Alternative Medicine Prospective, Cohort Study NCT00740233

Gastro-intestinal Diseases; Chronic Pain; Stress; Anxiety; Depression

Rec 1000 Adt Jun-08 Dec-10 Uni. of California, Los Angeles; National Center for Complementary and Alternative Medicine (NCCAM)


Preventing pain from interfering with later life: an action oriented qualitative study UKCRN ID 7916

Chronic pain Active 60 N/K N/K Oct-10 Keele University http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=7916

Somaethesia sensation and the perception of pain in rheumatic disease UKCRN ID 6276

Chronic pain; MSK conditions

Comp 174 N/K N/K Aug-10 Bath Royal National Hospital for Rheumatic Disease


Susceptibility to Chronic Post-Traumatic Extremity Pain Prospective, Case Control Study NCT00672711


Apr-08 Jul-10 William Beaumont Hospitals; Beaumont Foundation of America; Oakland Uni.


A Prevalence Study of Chronic Widespread Pain (CWP) Among Patients With Rheumatoid Arthritis (RA) and Control Population in Tallinn and Harjumaa County Cross-sectional, Case-Control NCT00721318

Chronic Widespread Pain

Active, NR

6000 Child Adt Sen

May-08

May-10 Estonian Society for Rheumatology













134

The Prevalence of Metabolic Syndrome in Patients Suffering From Chronic Pain Prospective, Cohort Study NCT00885261

Pain and Metabolic Syndrome

Rec 100 Adt Sen

May-09

Apr-10 Tel-Aviv Sourasky Medical Center


Evaluation of Assessments of Motor Performance, Physical Impairments and Functional Abilities Prospective NCT00747955

Healthy Not yet Rec

500 Child Adt Sen

Aug-08 ? Apr-10



Association Between Hypermobility and Chronic Musculoskeletal Pain Cross-sectional, Case-only NCT01032863

Hypermobility, Joint; Arthralgia; Myofascial Pain Syndromes; Fibromyalgia; Pain Disorder

Comp 112 Adt Dec-09 Mar-10 Amrita Institute of Medical Sciences & Research Center


Blood Sample Donations to Study the Role of Genes in Pain NCT00341367

Pain Comp 320 Child Adt Sen

Dec-02 Mar-10 National Institute on Alcohol Abuse and Alcoholism (NIAAA)


Pain Study to See if Ultram ER Will Provide Relief to Subjects Whose Pain is Not Well Controlled by Narcotics Prospective, Case-Control Study NCT00505531

Chronic Pain Active, NR

93 Adt Jun-07 Dec-09 Massachusetts General Hospital; Ortho-McNeil, Inc.


How chronic pain affects posture and movement: can motion capture technology enable us to separate the autonomic component of pain from communicative intent and other affective states? UKCRN ID 6456

Chronic Pain Active 50 N/K N/K Aug-09 University College London


Efficacy of Matrifen in Patients Older Than 18 Years With Severe, Chronic Pain Including Quality of Life Questionnaire Prospective, Case-only Study NCT00699335

Severe, Chronic Pain

Comp 7000 Adt Sen

Jun-08 May-09 Nycomed http://ClinicalTrials.gov/show/NCT00699335









135

Exploring justice issues in chronic pain: sufferer and partner perspectives Intervention? UKCRN ID 4547

Chronic pain Comp 130 N/K N/K Mar-09 Caledonian University Glasgow


Augmented Cerebral Pain Processing in Chronic, Unexplained Pain: a fMRI Study Cross-sectional NCT00463177


Mar-07 Jun-08 UMC Utrecht; K.F. Hein Stichting; Fonds Psychische Gezondheid


A11: PAIN

Title Phases: study design (control) NCT ID


Start Date

End Date

Sponsors URL


The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation Randomized, Factorial Assignment NCT01057368

Day of intensive meditation practice; Mindfulness Based Stress Reduction (MBSR); Health Enhancement Program (HEP)

Health; Mental Health

Rec 150 Adt Nov-09 Sep-12 University of Wisconsin, Madison; National Center for Complementary and Alternative Medicine (NCCAM)


Improvement of a Physically Active Lifestyle RCT (active), Efficacy Study NCT00979719

Interactive, computerized expert system (tailors treatment individual needs); interactive computerized standard program (proven to be effective); answer questions only

Pain; Osteoarthritis; Rheumatoid Arthritis; Heart Diseases; Diabetes Mellitus, Type 2; Behavior; Motivation

Rec 1000 Adt Sen

Oct-09 Mar-12 Freie Universitat Berlin; Deutsche Rentenversiche-rung Bund (DRV; German Retirement Insurance)







136

Long Term and Clinical Impact of the Lifestyle Management for Arthritis Programme (LMAP) for People with Inflammatory Arthritis Cohort Study UKCRN ID 4572

Lifestyle Management for Arthritis Programme; information-based programme

Inflammatory arthritis

Active 293 Adt Sen

N/K Feb-11 University of Salford, UK


Help Arthritis With Exercise in West Virginia Phase III: RCT (placebo), Safety/Efficacy Study NCT00526201

12-weeks EnhanceFitness; Control

Arthritis Active, NR

375 Adt Sen

May-08

Dec-10 Centers for Disease Control and Prevention; West Virginia University


Effect of Patient Education in Rheumatic Diseases Randomized, Parallel Assignment, Efficacy Study NCT00623922

Patient education with individual nurse consultations

Polyarthritis Active, NR

140 Adt Sen

Feb-08 Feb-10 Norwegian University of Science and Technology; The Research Council of Norway


Evaluation of Walk With Ease in Arthritis Phase III: Parallel Assignment (placebo), Safety/Efficacy Study NCT00526435

Walk with Ease - Group; Walk with Ease - Self; Control

Arthritis Not yet Rec

657 Adt Sen

Oct-07 Oct-09 Centers for Disease Control and Prevention; University of North Carolina


Pain and Stress Management for People With Rheumatoid Arthritis Phase II: RCT (active), Efficacy Study NCT00088764

Coping skills training; Written emotional disclosure; Arthritis education; Health behavior writing


Active, NR

280 Adt Sen

Feb-05 Jun-09 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Coping Skills Training for Early Rheumatoid Arthritis RCT (active), Efficacy Study NCT00056394

Comprehensive Coping Skills Training; Arthritis Education Sessions; Standard Care


Comp 225 Adt Sen

Feb-03 Apr-09 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Exercise Adherence Among Older Adults With Osteoarthritis RCT (active), Efficacy Study NCT00421681

Fit and Strong! Exercise Program

Osteoarthritis Active, NR

600 Adt Sen

Oct-03 Sep-08 National Institute on Aging (NIA)










137

RAHelp.Org: An Online Self Management Program for Adults With Rheumatoid Arthritis RCT (placebo), Efficacy Study NCT00283855

Online self-management program


Comp 200 Adt Sen

Oct-03 Sep-08 University of Missouri-Columbia; U.S. Department of Education


Device

Applications of Realtime Functional Magnetic Resonance Imaging (fMRI ) Single Group Assignment, Efficacy Study NCT01111617

Real-time fMRI feedback

Pain Not yet Rec

400 Adt May-10

Feb-12 Stanford University http://ClinicalTrials.gov/show/NCT01111617

The Effect of Alternative Keyboards on Discomfort and Typing Kinematics RCT (active), Safety/Efficacy Study NCT00801983

Alternative Keyboard

Pain Not yet Rec

70 Adt Jan-09 Mar-11 University of Pittsburgh; National Institute for Occupational Safety and Health (NIOSH/CDC)


Study to Evaluate ATP-induced Pain and ATP-induced Dermal Vasodilation by Iontophoresis Phase I: RCT (placebo), Efficacy Study NCT00917696

Iontophoresis and Laser Doppler with ATP; Iontophoresis and Laser Doppler with Saline

Osteoarthritis Pain

Rec 24 Adt

M-only

Oct-09 Jun-10 Merck http://ClinicalTrials.gov/show/NCT00917696

Effects of Transcranial Magnetic Stimulation (TMS) and Stimulus Controllability on Pain Perception RCT (placebo) NCT01030133

Transcranial Magnetic Stimulation

Pain Rec 100 Adt Sen

Oct-09 Feb-10 Medical University of South Carolina


Pain Monitoring Using Plurality of Non-invasive Physiological Measurement Single Group Assignment NCT00914173

Scanlaf Circulator and water bath; Medoc TSA 2000

Pain Comp 100 Adt Nov-08 Oct-09 Medasense Biometrics Ltd


Effect of Electroacupuncture on Pain Threshold Phase I: Randomized, Parallel Assignment, Efficacy Study NCT00802165

Electro-acupuncture; Sham electro-acupuncture

Pain Rec 40 Child Adt Sen

Dec-08 Apr-09 Logan College of Chiropractic









138

Far Infrared Radiation Treatment for Osteoarthritis Phase I: Single Group Assignment NCT00573352

Far Infrared Radiation

Osteoarthritis Active, NR

2 Child Adt Sen

Sep-06 Dec-08 GAAD Medical Research Institute Inc.


Management of Acute Pain in the Emergency Department Prospective, Cohort Study NCT00470652

Computer-assisted decision support


May-07

Sep-08 Centre Hospitalier Universitaire Vaudois; Societe Française de Medecine d'urgence


Dietry Supplement

Efficacy of Tart Cherry Juice to Reduce Pain and Inflammation Among Patients With Inflammatory Osteoarthritis Phase IV: Randomized, Parallel Assignment, Efficacy Study NCT01073982

Dietary Supplement: tart cultivar Montmorency cherry juice

Pain; Inflammation

Not yet Rec

20 Adt Sen

Feb-10 Aug-10 Oregon Health and Science University; Cherry Research Committee


Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis Phase III: RCT (active), Safety/Efficacy Study NCT00860873

EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder); EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules); Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder); Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)

Osteoarthrosis Not yet Rec

280 Adt Sen

May-09

May-10 L.A.L Clinica Pesquisa e Desenvolvimento Ltda.






139

Marine Oils and Arthritis Randomized, Parallel Assignment NCT00805116

Whale blubber oil; Cod liver oil


Term 80 Adt Sen

Dec-08 Oct-09 National Institute of Nutrition and Seafood Research, Norway



Subjective Analgesic Effects of Naloxone and Virtual Reality RCT (placebo), Efficacy Study NCT01105871

Naloxone; Placebo Pain Not yet Rec

50 Adt Aug-10 Jun-14 University of Washington


Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen Phase IV: Randomized, Parallel Assignment, Safety Study NCT00346216

Celecoxib; Ibuprofen; Naproxen

Arthritis, Rheumatoid; Osteoarthritis; Pain

Rec 20000 Adt Sen

Oct-06 Feb-13 Pfizer; The Cleveland Clinic


An Efficacy and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis (RA) Despite Treatment With Methotrexate, Non Steroidal Pain Medications and/or Corticosteroids Phase III: Randomized, Cross-over Assignment, Safety/Efficacy Study NCT00973479

Golimumab; Placebo

Arthritis, Rheumatoid

Rec 564 Adt Sen

N/K Dec-12 Centocor, Inc.; Schering-Plough


A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain Phase II: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00973141

JNJ-42160443; Placebo

Osteoarthritis; Osteoarthritis, Hip; Osteoarthritis, Knee; Pain; Arthralgia; Joint Pain

Active, NR

420 Adt Sen

N/K Sep-12 Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers Phase III: Randomized, Crossover Assignment, Pharmacokinetics/ Dynamics Study NCT01011036

Clobazam; Clonazepam; Tolterodine

Pain Rec 16 Adt

M-only

Dec-09 Nov-11 University Hospital Inselspital, Berne








140

Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA) Phase IV: Randomized, Crossover Assignment, Efficacy Study NCT01067430

Etoricoxib; Diclofenac


Not yet Rec

20 Adt Sen

Apr-10 Apr-11 Northumbria Healthcare NHS Foundation Trust


Role of Methadone As Co-Opioid Analgesic Phase II: RCT (active), Safety/Efficacy Study NCT00558870

Morphine; Methadone

Pain Rec 60 Adt Sen

Nov-07 Feb-11 M.D. Anderson Cancer Center


The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers Single Group Assignment (dose comparison), Efficacy Study NCT00657358

Lidocaine Pain Rec 10 Adt Sen

Apr-08 Dec-10 University of Alabama at Birmingham; American Society of Regional Anesthesia


The effect of ketamine and methadon on healthy volunteers with special focus on painscore, sedation, ventilatory depression and change of pupil diameter. RCT (placebo) NTR2039

Ketamine; Methadone intravenous

Analgesia N/K 48 Adt Jan-10 Sep-10 Leiden University Medical Centre


Evaluation of Propranolol's Effect on Pain and Inflammation. Randomized, Crossover Assignment, Efficacy Study NCT01094574

Propranolol Pain Measurement


Jan-10 Aug-10 Stanford University http://ClinicalTrials.gov/show/NCT01094574

Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus Omeprazole Phase III: Single Group Assignment, Safety/Efficacy Study NCT00971581

FDC Ketoprofen + Omeprazole

Pain Rec 50 Adt Sen

Aug-09 May-10 Sanofi-Aventis http://ClinicalTrials.gov/show/NCT00971581








141

An Exploratory Study to Assess the Effects of JNJ-39439335 on the Relief of Pain Using a Thermal-Grill Experimental Model Phase I: Randomized, Crossover Assignment, Pharmacodynamics Study NCT01006304

JNJ-39439335, Placebo

Pain Rec 12 Adt

M-only

Jun-09 May-10 Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


Effect of Spinal Ketorolac After Acute Opioid Exposure Phase II: Randomized, Parallel Assignment, Efficacy Study NCT00693160

Ketorolac; Placebo; Remifentanil

Healthy Rec 50 Adt Dec-07 Apr-10 Wake Forest University; National Institute of General Medical Sciences (NIGMS)


Acetaminophen and Impaired Musculoskeletal Adaptations to Exercise Training RCT (placebo) NCT01083901

Acetaminophen; Ibuprofen; Behavioral: high intensity progressive resistance exercise training; placebo

Sarcopenia; Osteoporosis; Aging

Active, NR

32 Adt Sen

M-

only

N/K ? Mar-10

University of Colorado, Denver


Effect of dronabinol on actual driving, simulated driving and the Standardized Field Sobriety Test. RCT (placebo) NTR1903

Dronabinol Pain N/K 24 Adt N/K Mar-10 University Maastricht (UM)


Efficacy and Safety of Salonsip Compared to SabiÃ¡ Plaster Phase III: RCT (active), Safety/Efficacy Study NCT00970658

Salonsip plaster; Sabia plaster

Contusions; Sprains; Myalgia; Pain; Tendonitis

Not yet Rec

70 Child Adt Sen

Dec-09 Feb-10 Hisamitsu Farmaceutica do Brasil Ltda


Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain Phase III: RCT (placebo) NCT00647127

Buprenorphine; Fentanyl; Placebo

Pain Rec 20 Adt

M-only

Feb-08 Jan-10 University of Aarhus









142

Effect of Ibuprofen, Paracetamol and Their Combination on Radical Oxygen Species (ROS) Production Phase IV: Non-Randomized, Crossover Assignment, Pharmacodynamics Study NCT00921505

Ibuprofen; Paracetamol (acetaminophen) 1000 mg; Paracetamol + ibuprofen

Pain Comp 7 Adt May-09

Jan-10 Ullevaal University Hospital; University of Oslo


Paracetamol as Antipyretic and Analgesic Medication Phase IV: Single Group Assignment, Safety/Efficacy Study NCT01070732

Paracetamol Fever; Analgesia Comp 100 Adt Sen

Jan-10 Jan-10 University of Athens


Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis Phase III: RCT (active), Safety Study NCT00092742

MK0663, etoricoxib; Diclofenac sodium

Rheumatoid Arthritis; Pain relief

Comp 4000 Adt Sen

Feb-03 ? Jan-10

Merck http://ClinicalTrials.gov/show/NCT00092742

Study of Epicutaneously Applied Ketoprofen TransfersomeÂ® Gel With or Without Combination With Oral Celecoxib for the Treatment of Muscle Pain Induced by Eccentric Exercise Phase I: RCT (placebo), Safety/Efficacy Study NCT01020279

Celecoxib, Ketoprofen; Ketoprofen

Musculoskeletal Pain

Comp 80 Adt Oct-09 Dec-09 X-pert Med GmbH http://ClinicalTrials.gov/show/NCT01020279

Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects Phase I: Randomized, Parallel Assignment, Safety Study NCT00972049

AZD2516; Placebo Healthy Comp 40 Adt Sen

Sep-09 Dec-09 AstraZeneca http://ClinicalTrials.gov/show/NCT00972049

To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects Phase I: Prospective, Cohort Study NCT00992316

PF-04531083 Pain Comp 80 Adt

M-only

Aug-09 Dec-09 Pfizer http://ClinicalTrials.gov/show/NCT00992316







143

Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects Phase I: RCT (placebo), Pharmacodynamics Study NCT00962663

ICA-105665; ibuprofen; Placebo

Nociceptive Pain; Hyperalgesia

Rec 24 Adt

M-only

Aug-09 Nov-09 Icagen http://ClinicalTrials.gov/show/NCT00962663

Protocolized vs Discretionary Use of Opioids in Acute Pain Phase III: RCT (active), Safety/Efficacy Study NCT00825370

Hydromorphone; IV opioid

Pain Rec 350 Adt Oct-08 Oct-09 Montefiore Medical Center


Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone Phase I: Randomized, Crossover Assignment, Bio-availability Study NCT00992381

PN400; Naprosyn Healthy Comp 24 Adt Sep-09 Oct-09 AstraZeneca; POZEN


A Safety and Effectiveness Pilot Study of PRF-108 in Healthy Volunteers Phase I/II: RCT (active), Safety/Efficacy Study NCT00883194

PRF-108; Placebo; Ropivacaine

Pain Not yet Rec

15 Adt Jul-09 Sep-09 PainReform LTD http://ClinicalTrials.gov/show/NCT00883194

A Study Comparing Norspan Patch and Oral Tramadol Phase IV: RCT (active), Safety/Efficacy Study NCT01019265

Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg

Osteoarthritis Comp 170 Adt Sen

Mar-08 May-09 Mundipharma Pte Ltd; Mundipharma YH (Korea) is the Sponsor; C&R Reaserch Inc. is the CRO


Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis Phase II: RCT (dose comparison), Safety/Efficacy Study NCT00504426

OPC-249 Pain Due to Osteoporosis

Comp 90 Adt Sen

F-

only

Jul-07 May-09 Otsuka Pharmaceutical Co., Ltd.








144

Relative Bioavailability and Food Effect Study Phase I: Randomized, Crossover Assignment, Pharmacokinetics Study NCT00827515

PH797804 Pain Wtdwn 16 Adt Feb-09 May-09 Pfizer http://ClinicalTrials.gov/show/NCT00827515

Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation Phase II: RCT (placebo), Efficacy Study NCT00349401

Ketorolac; Morphine

Pain Wtdwn 30 Adt Sen

Dec-06 ? May-09

Wake Forest University


Single Dose Pharmacokinetics of Egalet® Hydrocodone Phase I: RCT (active), Pharmacokinetics Study NCT00802087

Hydrocodone; Hydrocodone & Acetaminophen combination

Pain Comp 28 Adt Nov-08 Apr-09 Egalet a/s http://ClinicalTrials.gov/show/NCT00802087

Civamide Patch Safety, Tolerability and PK Study Phase I: RCT (placebo), Safety Study NCT00758433

Zucapsaicin; Placebo patch

Healthy Volunteers

Comp 39 Adt Sep-08 Apr-09 Winston Laboratories


First Time in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food of Single Ascending Doses of GSK1482160. Phase I: Randomized, Parallel Assignment, Safety Study NCT00849134

GSK1482160 or placebo

Pain Rec 32 Adt Nov-08 Mar-09 GlaxoSmithKline http://ClinicalTrials.gov/show/NCT00849134

Patient-Reported Effectiveness and Safety of Arcoxia in Osteoarthritis (OA) Phase IV: Single Group Assignment, Safety/Efficacy Study NCT00757627

Etoricoxib Pain, OA Comp 500 Adt Sen

Dec-07 Feb-09 Merck http://ClinicalTrials.gov/show/NCT00757627

Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Moderate Drinkers Phase I: RCT (placebo), Pharmacokinetics Study NCT00802308

Morphine sulphate Pain Comp 24 Adt Dec-08 Feb-09 Egalet a/s http://ClinicalTrials.gov/show/NCT00802308








145

Single Dose Pharmacokinetics of Egalet® Oxycodone Phase I: RCT (active), Pharmacokinetics Study NCT00801788

Oxycodone hydrochloride

Pain Comp 16 Adt Sep-08 Feb-09 Egalet a/s http://ClinicalTrials.gov/show/NCT00801788

A Study to Evaluate the Clinical Benefits of Tramadol/Acetaminophen (Ultracet) Versus Diclofenac in the Treatment of Pain in Patients With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs) Phase IV: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00766402

Tramadol /acetaminophen

Ankylosing Spondylitis; Pain

Term 4 Adt Sen

Sep-08 Feb-09 Johnson & Johnson Taiwan Ltd


Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects Phase I: Randomized, Parallel Assignment, Safety Study NCT00684502

AZD2066; Placebo Pain Comp 110 Adt Sen

Jan-08 Dec-08 AstraZeneca http://ClinicalTrials.gov/show/NCT00684502

A Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-03864086 In Healthy Male Subjects Phase I: Randomized, Crossover Assignment, Pharmacokinetics/ Dynamics Study NCT00747058

PF-3864086; Placebo

Pain Comp 28 Adt

M-only

Aug-08 Dec-08 Pfizer http://ClinicalTrials.gov/show/NCT00747058

A Study to Investigate the Tolerability and Effects on Epidermal Nerve Fiber Density of Multiple Low-Concentrations of NGX-1998 in Healthy Volunteers Phase I: RCT (placebo) NCT00912262

Capsaicin Topical Liquid

Pain Comp 36 Adt Jun-08 Nov-08 NeurogesX http://ClinicalTrials.gov/show/NCT00912262

Safety and Efficacy of Intravenous Acetaminophen in Adult Inpatients Phase III: RCT (active), Safety/Efficacy Study NCT00598559

IV Acetaminophen Acute Pain; Fever Comp 175 Adt Sen

Jan-08 Nov-08 Cadence Pharmaceuticals








146

Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers Phase I: RCT (placebo), Pharmacodynamics Study NCT00750048

Naloxone and paracetamol

Pain Comp 12 Adt

M-only

Sep-08 Nov-08 University Hospital, Clermont-Ferrand


Naproxen Sodium Extended-Release Actual Use Study Phase III: Single Group Assignment (dose comparison), Safety/Efficacy Study NCT00751400

Naproxen Sodium ER (BAYH6689)


Jul-08 Nov-08 Bayer; Pegus Research, Inc.


Naproxen Sodium ER Pharmacokinetic Study Phase I: Randomized, Crossover Assignment, Bio-availability Study NCT00818415

Naproxen sodium ER (BAYH6689); Commercial Naproxen (Aleve, BAYH6689)

Pain Comp 32 Adt Nov-08 Nov-08 Bayer http://ClinicalTrials.gov/show/NCT00818415

Treatment of Mild to Moderate Joint Pain in Patients With Chronic Plaque Psoriasis Receiving Efalizumab Phase IV: Non-randomized, Parallel Assignment, Safety/Efficacy Study NCT00510536

Acetaminophen; NSAID

Arthritis; Arthralgia

Comp 50 Adt Sen

Jul-07 Oct-08 Probity Medical Research


Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers Phase I: Randomized, Crossover Assignment, Pharmacodynamics Study NCT01119222

Gabapentin; Diphenhydramine; Morphine; Placebo

Healthy Comp 19 Adt

M-only

Jul-08 Oct-08 Pfizer http://ClinicalTrials.gov/show/NCT01119222

Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe Pain Phase III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00627367

Hydromorphone; Nonprotocolized

Acute Pain Active, NR

224 Adt Oct-07 Oct-08 Montefiore Medical Center








147

Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Subjects With Rheumatoid Arthritis Phase II: Randomized, Cross-over Assignment, Safety/Efficacy Study NCT00626275

ADL5859; naproxen; Placebo; Lactose monohydrate, NF


Comp 60 Adt Sen

Oct-07 Sep-08 Adolor Corporation http://ClinicalTrials.gov/show/NCT00626275

Safety and Speed of Onset of a Fixed Dose of Intravenous Hydromorphone in the Treatment of Adult Patients Presenting to the Emergency Department With Acute Severe Pain Phase IV: Non-randomized, Parallel Assignment, Safety/Efficacy Study NCT01006850

Hydromorphone Acute Pain Comp 300 Adt Sep-08 Montefiore Medical Center


Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-Treatment Seeking Marijuana Smokers Phase II: Single Group Assignment, Efficacy Study NCT00743119

Oral THC; Marijuana

Pain; Mood Rec 48 Adt

F-only

Jun-08 ? Aug-08

New York State Psychiatric Institute; Research Foundation for Mental Hygiene; National Institute on Drug Abuse


Study to Investigate Safety, Tolerability and Pharmacokinetics of a Single Ascending Dose of AZD1704 Phase I: Randomized, Parallel Assignment, Safety Study NCT00692042

AZD1704 Pain Comp 80 Adt Mar-08 Jun-08 AstraZeneca http://ClinicalTrials.gov/show/NCT00692042


Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment RCT (active) NCT01071447

Nurse-led clinic vs rheumatologist-led clinic

Rheumatic Diseases


Oct-09 Oct-12 Spenshult Hospital; The Swedish Rheumatism Association; County Council of Halland, Sweden







148

Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine Single Group Assignment, Efficacy Study NCT01059487

Traditional Chinese Medicine

Pain Management; Traditional Chinese Medicine

Not yet Rec

Adt Sen

Sep-10 Aug-12 Chicago College of Oriental Medicine|Agency for Healthcare Research and Quality (AHRQ)|QualityMetric Incorporated|Inspire Tech Group


Using Diffuse Noxious Inhibitory Control (DNIC) to Predict Acupuncture Therapy Outcome: A Pilot Study Single Group Assignment, Efficacy Study NCT01088867

Acupuncture Pain Rec 10 Adt Mar-10 Jan-11 University of Washington; Bastyr University


The effect of using copper heelers in alleviating joint and musculoskeletal aches and pains RCT (placebo) ISRCTN42466047

Copper heelers; Placebo heeler

Musculoskeletal pain and aches

Comp 200 Adt Sen

Mar-10 Mar-10 University of Wolverhampton Corporate Services Ltd (UK)


Does Auricular Acupuncture Improve Tolerance to Electromyography (EMG) Testing? Phase I: RCT (active), Efficacy Study NCT01017211

Auricular acupuncture

Pain Rec 36 Adt Sep-09 Jun-10 Kessler Foundation http://ClinicalTrials.gov/show/NCT01017211

Improving the provision of pain treatment for nursing home residents through consistent pain assessment - implementation of an algorithm for pain assessment (NRS - VRS - BESD) in nursing homes RCT (active) DRKS00000327

Nurse-training on pain with implementation of algorithm; Nurse-training on pain only

Pain; Older people

N/K 350 Sen Oct-09 > Dec-09

Akademisches Krankenhaus der Universität Ulm


Effectiveness of early part-time sick leave in musculoskeletal disorders RCT ISRCTN30911719

Part-time sick leave; full-time sick leave

Musculoskeletal disorders

Comp 600 Adt Jan-08 Jun-09 Finnish Institute of Occupational Health












149


Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica Prospective, Case-Control StudyProspective NCT00847236

Polymyalgia Rheumatica; Rheumatoid Arthritis; Rheumatic Disease

Rec 150 Adt Sen

Jan-09 Mar-11 Lahey Clinic http://ClinicalTrials.gov/show/NCT00847236

A survey of GPs views on the prognosis of osteoarthritis - The prognosis of joint pain in the older adult : GPs views on discussing and estimating prognosis Cross-sectional, Cohort Study UKCRN ID 7722

Joint pain; OA Active 500 Adt Sen

N/K Dec-10 Keele University, UK


Preventing pain from interfering with later life: an action oriented qualitative study UKCRN ID 7916

Pain Active 60 N/K N/K Oct-10 Keele University, UK


Cognitive Testing for the Pain Quality Assessment Scale (PQAS) Prospective, Cross-Sectional, Case-Control Study NCT00715598

Pain; Spinal Cord Injuries; Multiple Sclerosis; Diabetes Complications

Enrolling by

invitation

225 Adt Sen

Jun-08 Aug-10 University of Washington; Merck


MRI Study of Musculoskeletal Function NCT00051857

Healthy Rec 500 Child Adt

Jan-03 ? Jun-10

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


Natural History of Rheumatic Diseases in Minority Communities NCT00024479

Rheumatic Disease

Rec N/K Adt Sen

Sep-01 ? Mar-10



Distraction from pain in Fibromyalgia, Arthritis and healthy volunteers Observational UKCRN ID 4779

Fibromyalgia; Pain; Arthritis

Active 48 N/K N/K Dec-09 N/K http://public.ukcrn.org.uk/Search/ StudyDetail.aspx?StudyID=4779











150

Acute Pain Episodes in Patients Under Opioid Maintenance Therapy : Clinical Management and Long Term Effects Prospective, Cohort Study NCT00738036

Acute Pain Comp 150 Adt Sen

Apr-08 Nov-09 University Hospital, Toulouse; French Health Products Safety Agency


Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases NCT00069342

Rheumatic Diseases

Comp 140 Adt Sen

Sep-03 ? Nov-09



Additional Positron Emission Tomography (PET) Scan of Brain in Patients Undergoing PET Scan for Diseases Unrelated to Brain Prospective, Cohort Study NCT00729092

Pain Active, NR

100 Adt Sen

May-08

Oct-09 Rush University Medical Center


Elaboration of a patient derived score to measure osteoarthritis impact of diseas based on a patient's perception of pain and functional disability an OARSI-OMERACT initiative UKCRN ID 6482

OA; Pain; Disability

Comp 200 N/K N/K Jul-09 Chapel Allerton Hospital, Leeds, UK


Investigating the Impact of Mode of Administration on Item Response Cross-Sectional NCT00783991

Chronic Obstructive Pulmonary Disease; Depression; Rheumatoid Arthritis

Not yet Rec

800 Adt Sen

Apr-09 May-09 National Institutes of Health (NIH); QualityMetrics; Stony Brook University; NorthShore University HealthSystem Research Institute; Stanford University


PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders Prospective, Cohort Study NCT00922428

Rheumatic Disorders; Arthralgia; Myalgia; Lumbago

Comp 1389 Adt Sen

Jan-09 May-09 Pascoe Pharmazeutische Praeparate GmbH


The prognosis of musculoskeletal pain in primary care 2 UKCRN ID 5968

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151

The Role of Sustained Attention in Regulating Pain UKCRN ID 4780

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Susp 36 N/K N/K Dec-08 Hope Hospital, Manchester, UK


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Pain; OA; Fibromyalgia; Healthy

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Osteoarthritis; Arthritis, Rheumatoid

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Mar-07 May-08 Boehringer Ingelheim Pharmaceuticals


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HORIZON SCANNING MUSCULOSKELETAL PAIN DISORDERS JUNE … · 3 Dietary Supplement 104 Drugs...

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